BD GeneOhm Cdiff Assay — Class II medical device recall Z-0790-2014
Terminated recall by Becton Dickinson & Co., reported 2014-01-29, distributed in CA, IN, MA, MN, NJ, NY, OH, PA…. An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved res
| Recall number | Z-0790-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2013-10-11 |
| Classified | 2014-01-17 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-02-19 |
| Distributed | CA, IN, MA, MN, NJ, NY, OH, PA, SD, UT |
| Quantity | 33 kits |
| Lot numbers | 08T13108 |
| Model numbers | 441401 |
| Expiration dates | 2013-12-24 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0790-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.