Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BD GeneOhm Cdiff Assay Recalled by Becton Dickinson & Co. Due to Leakage in Cepheid SmartCycler reaction tubes.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Becton Dickinson & Co. directly.
Affected Products
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.
Quantity: 32 kits
Why Was This Recalled?
Leakage in Cepheid SmartCycler reaction tubes.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Becton Dickinson & Co.
Becton Dickinson & Co. has 183 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report