BD GeneOhm Cdiff Assay — Class II medical device recall Z-2318-2012
Terminated recall by Becton Dickinson & Co., reported 2012-09-12, distributed nationwide. Leakage in Cepheid SmartCycler reaction tubes.
| Recall number | Z-2318-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2012-05-22 |
| Classified | 2012-09-06 |
| Reported by FDA | 2012-09-12 |
| Terminated | 2012-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 57 kits |
| Reason classes | packaging |
| Lot numbers | 08T11248, 08T11251 |
| Model numbers | 200, 441400 |
Product
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 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 fr.om 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.
Reason for recall
Leakage in Cepheid SmartCycler reaction tubes.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.