CLASS II Device recall · Reported 12 Sep 2012 · FDA Enforcement Report

BD GeneOhm Cdiff Assay recalled by Becton Dickinson &

Becton Dickinson & is recalling BD GeneOhm Cdiff Assay, distributed nationwide in the US. The recall was initiated on 22 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/ Exp. 08T11250 2012-07-06

Quantity recalled32 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2319-2012
FDA event ID: 62505
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 22 May 2012
FDA classified: 6 Sep 2012
Reported: 12 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Botulism
Device type: Test Kits & Diagnostics

Timeline

22 May 2012	Recall initiated by company
6 Sep 2012	Classified by FDA	+107 days
12 Sep 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Leakage in Cepheid SmartCycler reaction tubes.

Product as listed by the FDA

BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

Where it was distributed

Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.

Nationwide California Delaware Florida Georgia Illinois Indiana Kansas Kentucky Maine Montana North Carolina New Jersey New Mexico New York Ohio Oklahoma Pennsylvania South Carolina Texas Virginia

Stores named: Target

Questions about this recall

Is BD GeneOhm Cdiff Assay recalled?

Yes. Becton Dickinson & recalled BD GeneOhm Cdiff Assay on 22 May 2012. The recall is Class II and its status is Terminated. Recall number Z-2319-2012.

Why was it recalled?

Leakage in Cepheid SmartCycler reaction tubes.

Which lots are affected?

Lot/ Exp. 08T11250 2012-07-06

Where was it sold?

Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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