BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sci
FDA device recall Z-0790-2014 · posted 2014-01-17 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- 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.
- Action taken
- Becton Dickinson sent an Urgent Product Recall Letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They were advised that a portion of the BD GeneOhm Cdiff assay test kits from one lot, 08T13108, may contain incorrect bags of sample buffer tube. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was discarded. Please fax to 410-316-4258.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LLH
- Quantity affected
- 33 kits
- Distribution
- US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
- Date initiated
- 2013-10-11
- Date posted
- 2014-01-17
- Date terminated
- 2014-02-19
- Location
- Sparks, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD GENEOHM CDIFF ASSAY (K081920) | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008-12-19 |