Z-1963-2009

BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the...

Name: Z-1963-2009 BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the...
Creator: BD Diagnostics (GeneOhm Sciences, Inc)
Published: 2008-11-11
License: https://open.fda.gov/license/

BD Diagnostics (Geneohm Sciences, Inc.) / initiated 2008-11-11 / Terminated / root cause: packaging

FDA source

BD Diagnostics (GeneOhm Sciences, Inc) began a recall of 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... on 2008-11-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1963-2009
Status: Terminated
Initiated: 2008-11-11
Posted: 2009-09-10
Terminated: 2011-11-29
Recalling firm: BD Diagnostics (Geneohm Sciences, Inc.)
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.
Product code: NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
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.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Catalog Number: 441242, Lot Numbers: 03T08206, 03T08207, 03T08207a and 03T08221a; and Catalog Number: 441244, Lot Number: 03T08218.

Product code NQX

K042357Class IIIdi-Mrsa AssayInfectio Diagnostic (I.D.I.), Inc. / cleared 2004-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)