CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report
BD GeneOhm Cdiff Assay, Part #441401 recalled by Becton Dickinson &
Becton Dickinson & is recalling BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200, distributed in 10 states. The recall was initiated on 11 Oct 2013 and the FDA has classified it as Class II.
Check your package
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-0790-2014
- FDA event ID
- 66933
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2013
- FDA classified
- 17 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Botulism
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Oct 2013 | Recall initiated by company | |
| 17 Jan 2014 | Classified by FDA | +98 days |
| 29 Jan 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
Product as listed by the FDA
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B 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.
Where it was distributed
US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
CaliforniaIndianaMassachusettsMinnesotaNew JerseyNew YorkOhioPennsylvaniaSouth DakotaUtah
Questions about this recall
Is BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 recalled?
Yes. Becton Dickinson & recalled BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 on 11 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0790-2014.
Why was it recalled?
An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
Which lots are affected?
Lot 08T13108 Exp Dec 24 2013
Where was it sold?
US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
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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