Device recall: BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit…

Class II FDA enforcement event 65619. Recall start date: 13 Jun 2013. Status in the FDA record: Terminated. Termination date: 28 Sep 2013.

Reason for recall, in the words of FDA

In vitro diagnostic test kit may exhibit invalid internal negative control results.

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 13 Jun 2013. The firm address in the FDA record is in Sparks, MD. FDA put the recall in Class II. FDA event 65619 has 1 product record. The first FDA enforcement report date is 7 Aug 2013. The record gives the status Terminated, with the termination date 28 Sep 2013.

FDA enforcement report The 1 product record

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

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

1 product record in the event.

FDA event 65619: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1812-2013	BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part *Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds* The Affirm VPIII Microbial Identification Test is a DNA…	177 kits	Class II	Terminated	7 Aug 2013

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 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 1Median 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-1812-2013The 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.

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Cite this page

Recall Register. FDA enforcement event 65619. https://recallregister.com/fda/ii/65619/. 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
What quantity of product is in FDA event 65619?: The FDA record gives this quantity: 177 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.