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 An incorrect reagent was packed with an in...
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, 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.
Quantity: 33 kits
Why Was This 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.
Where Was This Sold?
This product was distributed to 10 states: CA, IN, MA, MN, NJ, NY, OH, PA, SD, UT
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