Device recall: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram…

Class I FDA enforcement event 73413. Recall start date: 24 Feb 2016. Status in the FDA record: Terminated. Termination date: 8 Mar 2018.

Reason for recall, in the words of FDA

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Biomerieux Inc started this device recall on 24 Feb 2016. The firm address in the FDA record is in Hazelwood, MO. FDA put the recall in Class I. FDA event 73413 has 9 product records. The first FDA enforcement report date is 18 May 2016. The record gives the status Terminated, with the termination date 8 Mar 2018.

FDA enforcement report The 9 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.

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

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

9 product records in the event.

FDA event 73413: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1639-2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.…	495 kits	Class I	Terminated	18 May 2016
Z-1640-2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.…	180 kits	Class I	Terminated	18 May 2016
Z-1641-2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.…	7,497 kits	Class I	Terminated	18 May 2016
Z-1642-2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.…	3,594 kits	Class I	Terminated	18 May 2016
Z-1643-2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.…	15,006 kits	Class I	Terminated	18 May 2016
Z-1644-2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.…	2,570 kits	Class I	Terminated	18 May 2016
Z-1645-2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.…	5,575 kits	Class I	Terminated	18 May 2016
Z-1646-2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.…	1,524 kits	Class I	Terminated	18 May 2016
Z-1647-2016	Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.…	1,035 kits	Class I	Terminated	18 May 2016

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 I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class I: 3%
Product records in this event: 9Median 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-1639-2016The 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 73413. https://recallregister.com/fda/i/73413/. 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: Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
What quantity of product is in FDA event 73413?: The event has 9 product records. The first record gives this quantity: 495 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 3% of the 1,232 device events that started in 2016 are in Class I.