Device recall: VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.

Class II FDA enforcement event 77026. Recall start date: 20 Apr 2017. Status in the FDA record: Terminated. Termination date: 22 Jul 2020.

Reason for recall, in the words of FDA

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Biomerieux Inc started this device recall on 20 Apr 2017. The firm address in the FDA record is in Hazelwood, MO. FDA put the recall in Class II. FDA event 77026 has 187 product records. The first FDA enforcement report date is 21 Jun 2017. The record gives the status Terminated, with the termination date 22 Jul 2020.

FDA enforcement report The 187 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus,…

Recalling firm

Biomerieux Inc, Hazelwood, MO.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

187 product records in the event.

FDA event 77026: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2341-2017	VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.	177,828 cartons	Class II	Terminated	21 Jun 2017
Z-2342-2017	VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.	70,261 cartons	Class II	Terminated	21 Jun 2017
Z-2343-2017	VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .	5192 cartons	Class II	Terminated	21 Jun 2017
Z-2344-2017	VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.	583 cartons	Class II	Terminated	21 Jun 2017
Z-2345-2017	VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton.	4125 cartons	Class II	Terminated	21 Jun 2017
Z-2346-2017	VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.	6316 cartons	Class II	Terminated	21 Jun 2017
Z-2347-2017	VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.	3,197 cartons	Class II	Terminated	21 Jun 2017
Z-2348-2017	VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton.	18,156 cartons	Class II	Terminated	21 Jun 2017
Z-2349-2017	VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton.	0	Class II	Terminated	21 Jun 2017
Z-2350-2017	VITEK 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton.	488 cartons	Class II	Terminated	21 Jun 2017
Z-2351-2017	VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.	9,817 cartons	Class II	Terminated	21 Jun 2017
Z-2352-2017	VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton.	1,533 cartons	Class II	Terminated	21 Jun 2017
Z-2353-2017	VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.	75,502 cartons	Class II	Terminated	21 Jun 2017
Z-2354-2017	VITEK 2 Gram Positive Susceptibility card (AST-GP68), REF 22231, 20 cards per carton.	1,974 cartons	Class II	Terminated	21 Jun 2017
Z-2355-2017	VITEK 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards per carton.	2,390 cartons	Class II	Terminated	21 Jun 2017
Z-2356-2017	VITEK 2 Gram Positive Susceptibility card (AST-P584), REF 22252, 20 cards per carton.	499 cartons	Class II	Terminated	21 Jun 2017
Z-2357-2017	VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton.	978 cartons	Class II	Terminated	21 Jun 2017
Z-2358-2017	VITEK 2 Gram Positive Susceptibility card (AST-P586), REF 22276, 20 cards per carton.	4,089 cartons	Class II	Terminated	21 Jun 2017
Z-2359-2017	VITEK 2 Gram Positive Susceptibility card (AST-P592), REF 22287, 20 cards per carton.	3,384 cartons	Class II	Terminated	21 Jun 2017
Z-2360-2017	VITEK 2 Gram Positive Susceptibility card (AST-P597), REF 22298, 20 cards per carton.	1,247 cartons	Class II	Terminated	21 Jun 2017
Z-2361-2017	VITEK 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton.	315 cartons	Class II	Terminated	21 Jun 2017
Z-2362-2017	VITEK 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.	1,487 cartons	Class II	Terminated	21 Jun 2017
Z-2363-2017	VITEK 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards per carton.	1,051 cartons	Class II	Terminated	21 Jun 2017
Z-2364-2017	VITEK 2 Gram Positive Susceptibility card (AST-P605), REF 22325 20 cards per carton.	817 cartons	Class II	Terminated	21 Jun 2017
Z-2365-2017	VITEK 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards per carton.	N/A	Class II	Terminated	21 Jun 2017
Z-2366-2017	VITEK 2 Gram Negative Susceptibility card (AST-GN38), REF 22331, 20 cards per carton.	824 cartons	Class II	Terminated	21 Jun 2017
Z-2367-2017	VITEK 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton.	1,182 cartons	Class II	Terminated	21 Jun 2017
Z-2368-2017	VITEK 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton.	1,232 cards	Class II	Terminated	21 Jun 2017
Z-2369-2017	VITEK 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton.	3,387 cartons	Class II	Terminated	21 Jun 2017
Z-2370-2017	VITEK 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per carton.	425 cartons	Class II	Terminated	21 Jun 2017
Z-2371-2017	VITEK 2 Gram Positive Susceptibility card (AST-P613), REF 410027, 20 cards per carton.	490 cartons	Class II	Terminated	21 Jun 2017
Z-2372-2017	VITEK 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.	19,398 cartons	Class II	Terminated	21 Jun 2017
Z-2373-2017	VITEK 2 Gram Positive Susceptibility card (AST-P616), REF 410223, 20 cards per carton.	2,260 cartons	Class II	Terminated	21 Jun 2017
Z-2374-2017	VITEK 2 Gram Negative Susceptibility card (AST-XN04), REF 410401, 20 cards per carton.	3124 cartons	Class II	Terminated	21 Jun 2017
Z-2375-2017	VITEK 2 Gram Positive Susceptibility card (AST-GP71), REF 410750, 20 cards per carton.	1972 cartons	Class II	Terminated	21 Jun 2017
Z-2376-2017	VITEK 2 Gram Positive Susceptibility card (AST-P618), REF 410806, 20 cards per carton.	487 cartons	Class II	Terminated	21 Jun 2017
Z-2377-2017	VITEK 2 Gram Positive Susceptibility card (AST-P619), REF 411944, 20 cards per carton.	2,181 cartons	Class II	Terminated	21 Jun 2017
Z-2378-2017	VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.	2251 cartons	Class II	Terminated	21 Jun 2017
Z-2379-2017	VITEK 2 Gram Negative Susceptibility card (AST-GN48), REF 412090, 20 cards per carton.	1,192 cartons	Class II	Terminated	21 Jun 2017
Z-2380-2017	VITEK 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.	32,628 cartons	Class II	Terminated	21 Jun 2017
Z-2381-2017	VITEK 2 Gram Positive Susceptibility card (AST-P621), REF 412533, 20 cards per carton.	1,005 cartons	Class II	Terminated	21 Jun 2017
Z-2382-2017	VITEK 2 Gram Negative Susceptibility card (AST-N190), REF 412548, 20 cards per carton.	9224 cartons	Class II	Terminated	21 Jun 2017
Z-2383-2017	VITEK 2 Gram Negative Susceptibility card (AST-N193), REF 412604, 20 cards per carton.	1,592 cartons	Class II	Terminated	21 Jun 2017
Z-2384-2017	VITEK 2 Gram Negative Susceptibility card (AST-N194), REF 412605, 20 cards per carton.	N/A	Class II	Terminated	21 Jun 2017
Z-2385-2017	VITEK 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per carton.	N/A	Class II	Terminated	21 Jun 2017
Z-2386-2017	VITEK 2 Gram Negative Susceptibility card (AST-N195), REF412609, 20 cards per carton.	1,226 cartons	Class II	Terminated	21 Jun 2017
Z-2387-2017	VITEK 2 Gram Negative Susceptibility card (AST-N201), REF 412862, 20 cards per carton.	5559 cartons	Class II	Terminated	21 Jun 2017
Z-2388-2017	VITEK 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per carton.	6813 cartons	Class II	Terminated	21 Jun 2017
Z-2389-2017	VITEK 2 Gram Negative Susceptibility card (AST-N203), REF 412864, 20 cards per carton.	2,239 cartons	Class II	Terminated	21 Jun 2017
Z-2390-2017	VITEK 2 Gram Negative Susceptibility card (AST-N204), REF 412865, 20 cards per carton..	6275 cartons	Class II	Terminated	21 Jun 2017
Z-2391-2017	VITEK 2 Gram Negative Susceptibility card (AST-N209), REF 412938, 20 cards per carton.	1,065 cartons	Class II	Terminated	21 Jun 2017
Z-2392-2017	VITEK 2 Gram Negative Susceptibility card (AST-N211), REF 413043, 20 cards per carton.	568 cartons	Class II	Terminated	21 Jun 2017
Z-2393-2017	VITEK 2 Gram Negative Susceptibility card (AST-N212), REF 413061, 20 cards per carton.	511 cartons	Class II	Terminated	21 Jun 2017
Z-2394-2017	VITEK 2 Gram Negative Susceptibility card (AST-N208), IVD, REF 413062, 20 cards per carton.	4709 cartons	Class II	Terminated	21 Jun 2017
Z-2395-2017	VITEK 2 Gram Negative Susceptibility card (AST-N213), REF 413063, 20 cards per carton.	3665 cartons	Class II	Terminated	21 Jun 2017
Z-2396-2017	VITEK 2 Gram Negative Susceptibility card (AST-N214), REF 413064, 20 cards per carton.	3382 cartons	Class II	Terminated	21 Jun 2017
Z-2397-2017	VITEK 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton.	536 cartons	Class II	Terminated	21 Jun 2017
Z-2398-2017	VITEK 2 Gram Negative Susceptibility card (AST-N216), REF 413066, 20 cards per carton.	1181 cartons	Class II	Terminated	21 Jun 2017
Z-2399-2017	VITEK 2 Gram Negative Susceptibility card (AST-N217), REF 413080, 20 cards per carton.	512 cartons	Class II	Terminated	21 Jun 2017
Z-2400-2017	VITEK 2 Gram Negative Susceptibility card (AST-N222), REF 413083, 20 cards per carton.	2554 cartons	Class II	Terminated	21 Jun 2017

The table shows 60 of 187 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2017: 1,091
Share of these events in Class II: 93%
Product records in this event: 187Median of the firm: 1
Events of the firm on the register: 57

Other events of the firm

Other FDA enforcement events of Biomerieux Inc
Initiated	Product (first record)	Type	Class	Records
4 Jun 2026	VITEK 2 AST-N447 TEST KIT Product reference 424620	Device	Class II	1
5 Jan 2026	VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem	Device	Class II	1
26 Jun 2025	VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consis	Device	Class II	1
14 Mar 2024	VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) A	Device	Class I	1
6 Feb 2023	MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments f	Device	Class II	1
9 Nov 2022	API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300	Device	Class II	94
20 Jul 2022	NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.	Device	Class II	1
13 Jul 2022	VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8	Device	Class II	1
29 Mar 2022	VITEK 2 Systems and VITEK 2 with MYLA.	Device	Class II	1
9 Feb 2022	VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.	Device	Class II	1

Biomerieux Inc: all 57 events

Official channels

FDA enforcement report Z-2341-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 77026. https://recallregister.com/fda/ii/77026/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus,…
What quantity of product is in FDA event 77026?: The event has 187 product records. The first record gives this quantity: 177,828 cartons
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 93% of the 1,091 device events that started in 2017 are in Class II.