Device recall: Kit BD Max Check-Points CPO IVD EU; Catalog # 278102

Class II FDA enforcement event 83406. Recall start date: 17 Jul 2019. Status in the FDA record: Terminated. Termination date: 13 May 2020.

Reason for recall, in the words of FDA

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

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

Becton Dickinson & Co. started this device recall on 17 Jul 2019. The firm address in the FDA record is in Sparks, MD. FDA put the recall in Class II. FDA event 83406 has 19 product records. The first FDA enforcement report date is 28 Aug 2019. The record gives the status Terminated, with the termination date 13 May 2020.

FDA enforcement report The 19 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.

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada,…

Recalling firm

Becton Dickinson & Co., Sparks, MD.

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

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

Products

19 product records in the event.

FDA event 83406: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2321-2019	Kit BD Max Check-Points CPO IVD EU; Catalog # 278102	130 units	Class II	Terminated	28 Aug 2019
Z-2322-2019	Kit BD Max Cdiff EU; Catalog # 442555	4 units	Class II	Terminated	28 Aug 2019
Z-2323-2019	Kit BD Max ExK DNA 1 USA; Catalog # 442817	115 units	Class II	Terminated	28 Aug 2019
Z-2324-2019	Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818	447 units	Class II	Terminated	28 Aug 2019
Z-2325-2019	Kit BD Max ExK DNA 2 USA; Catalog # 442819	0	Class II	Terminated	28 Aug 2019
Z-2326-2019	Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820	10 units	Class II	Terminated	28 Aug 2019
Z-2327-2019	Kit BD Max ExK TNA 2; Catalog # 442825	86 units	Class II	Terminated	28 Aug 2019
Z-2328-2019	Kit BD Max MRSA; Catalog # 442953	176 units	Class II	Terminated	28 Aug 2019
Z-2329-2019	Kit BD Max Enteric Parasite Panel EU; Catalog # 442960	355 units	Class II	Terminated	28 Aug 2019
Z-2330-2019	Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963	994 units	Class II	Terminated	28 Aug 2019
Z-2331-2019	Kit BD Max CT/GC/TV; Catalog # 442970	913 units	Class II	Terminated	28 Aug 2019
Z-2332-2019	Kit BD Max StaphSR; Catalog # 443418	283 units	Class II	Terminated	28 Aug 2019
Z-2333-2019	Kit BD Max StaphSR; Catalog # 443419	207 units	Class II	Terminated	28 Aug 2019
Z-2334-2019	Kit BD Max MRSA XT; Catalog # 443461	61 units	Class II	Terminated	28 Aug 2019
Z-2335-2019	Kit BD Max GC RT PCR Assay; Catalog # 443486	17 units	Class II	Terminated	28 Aug 2019
Z-2336-2019	Kit BD Max Vaginal Panel; Catalog # 443712	666 units	Class II	Terminated	28 Aug 2019
Z-2337-2019	Kit BD Max Enteric Viral Panel RUO; Catalog # 443715	27units	Class II	Terminated	28 Aug 2019
Z-2338-2019	Kit EXT Enteric Bacterial Panel; Catalog # 443812	715 units	Class II	Terminated	28 Aug 2019
Z-2339-2019	Kit BD Max Enteric Viral Panel EU Catalog # 443985	469 units	Class II	Terminated	28 Aug 2019

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 2019: 968
Share of these events in Class II: 88%
Product records in this event: 19Median of the firm: 1
Events of the firm on the register: 77

Other events of the firm

Other FDA enforcement events of Becton Dickinson & Co.
Initiated	Product (first record)	Type	Class	Records
7 Apr 2026	BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use	Device	Class II	2
23 Oct 2025	BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;	Device	Class II	1
23 Sep 2025	BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Nu	Device	Class II	6
23 Jun 2025	BD COR System Software. Model Number: 444829.	Device	Class II	1
20 May 2025	BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from cul	Device	Class II	1
12 Feb 2025	BD BBL TB Stain Kit K, Catalog (REF): 212522	Device	Class II	1
19 Dec 2024	BD PCR Cartridges used with MAX System. Model Number: 437519	Device	Class II	1
6 Nov 2024	BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used for semi-quantitativ	Device	Class II	1
31 Oct 2024	BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007	Device	Class II	13
12 Sep 2024	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory soft	Device	Class II	1

Becton Dickinson & Co.: all 77 events

Official channels

FDA enforcement report Z-2321-2019The 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 83406. https://recallregister.com/fda/ii/83406/. 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: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada,…
What quantity of product is in FDA event 83406?: The event has 19 product records. The first record gives this quantity: 130 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.