BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologi
FDA device recall Z-2174-2010 · posted 2010-08-05 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- In vitro diagnostic test kits do not perform to specifications.
- Action taken
- The recalling firm notified accounts by an Urgent Product Recall letter on 03/05/2020. The letter identified the affected product and explained the reason for recall. It also advised customers to discontinue use of the affected product and discard any remaining inventory and fax back an acknowledgement form. The letter stated that BD will provide replacements for any discarded product. Further assistance can be obtained by contacting BD Technical Service at 1-888-436-3646.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LLH
- Quantity affected
- 31 kits
- Distribution
- Nationwide Distribution -- IL, IN, PA, WA, CA, VA, NJ, and KS.
- Date initiated
- 2010-03-05
- Date posted
- 2010-08-05
- Date terminated
- 2010-10-15
- Location
- Sparks, MD
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD GENEOHM CDIFF ASSAY (K081920) | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008-12-19 |