FDA Device recall Z-0790-2014
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit
- FDA Device
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit by Becton Dickinson And, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0790-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-11 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | CA, IN, MA, MN, NJ, NY, OH, PA, SD, UT |
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
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.
Identifiers
| code_info | Lot 08T13108 Exp Dec 24 2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0790-2014%22
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