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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
BD Diagnostics (GeneOhm Sciences, Inc)
Lot Codes / Batch Numbers
Catalog Number: 441242, Lot Numbers: 03T08206, 03T08207, 03T08207a and 03T08221a, and Catalog Number: 441244, Lot Number: 03T08218.
Products Sold
Catalog Number: 441242, Lot Numbers: 03T08206, 03T08207, 03T08207a and 03T08221a; and Catalog Number: 441244, Lot Number: 03T08218.
BD Diagnostics (GeneOhm Sciences, Inc) is recalling BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). due to BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above ma. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IL, IN, ME, MD, MN, MO, MT, NJ, NY, NC, OK, PA, TN, TX, UT, VA, WI
Page updated: Jan 10, 2026