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.
FDA Recall Z-1963-2009 · Posted 2009-09-10
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Recalling FirmBD Diagnostics (GeneOhm Sciences, Inc)
Recall StatusTerminated
Product CodeNQX
Date Initiated2008-11-11
Date Terminated2011-11-29
Product Quantity114 kits
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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