Recall Z-1963-2009 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
BD Diagnostics (GeneOhm Sciences, Inc)
BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.
| Date | Sep 10, 2009 (initiated Nov 11, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042357 | IDI-MRSA ASSAY Infectio Diagnostic (I.D.I.), Inc., Oct 22, 2004 |