Recall Z-1963-2009
BD Diagnostics (GeneOhm Sciences, Inc) · initiated November 11, 2008
Product
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.
Codes / lots: Catalog Number: 441242, Lot Numbers: 03T08206, 03T08207, 03T08207a and 03T08221a; and Catalog Number: 441244, Lot Number: 03T08218.
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.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-1963-2009
- Initiated
- November 11, 2008
- Posted by FDA
- September 10, 2009
- Terminated
- November 29, 2011
- Product code
- NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- 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.
- Recalling firm
- BD Diagnostics (GeneOhm Sciences, Inc), San Diego, CA