BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detect
FDA device recall Z-1963-2009 · posted 2009-09-10 · Terminated
Recall details
- Recalling firm
- BD Diagnostics (GeneOhm Sciences, Inc)
- Reason for recall
- BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.
- Action taken
- BD Diagnostics GeneOhm began contacting consignees by phone November 17, 2008 followed by a letter dated November 21, 2008 instructing discontinued use of the affected lots. Consignees were also asked to complete and return the enclosed Field Action Verification form. To arrange for product replacement or for further information, contact BD Diagnostics Technical Service at 1-888-436-3646 extension 2.
- Root cause
- Other
- Status
- Terminated
- Product code
- NQX
- Quantity affected
- 114 kits
- Distribution
- Worldwide Distribution -- US (CA, IL, IN, KT, MD, ME, MN, MO, MT, NC, NJ, NY, OK, PA, TN, TX, UT, VA, and WI), Belgium and Japan.
- Date initiated
- 2008-11-11
- Date posted
- 2009-09-10
- Date terminated
- 2011-11-29
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IDI-MRSA ASSAY (K042357) | Infectio Diagnostic (I.D.I.), Inc. | 2004-10-22 |