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

BD GeneOhm MRSA ACP Assay recalled by Becton Dickinson &

Becton Dickinson & is recalling BD GeneOhm MRSA ACP 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. 03T11345ZU 2012-07-09

Quantity recalled68 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-2317-2012
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: Potency & Assay
Device type: Patient Monitors

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. .

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

Questions about this recall

Is BD GeneOhm MRSA ACP Assay recalled?

Yes. Becton Dickinson & recalled BD GeneOhm MRSA ACP Assay on 22 May 2012. The recall is Class II and its status is Terminated. Recall number Z-2317-2012.

Why was it recalled?

Leakage in Cepheid SmartCycler reaction tubes.

Which lots are affected?

Lot/ Exp. 03T11345ZU 2012-07-09

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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