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BD GeneOhm™ StaphSR assay 48 TestsA
Geneohm Sciences Canada Inc · Model 441448 · UDI-DI 00382904414481
NQX
Prescription
10
510(k) clearances
58
Adverse events (7 deaths)
20
Recalls
11
Facilities
Description
Kit BD GeneOhm StaphSR 48 USA
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-06 | Cepheid | As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. |
| 2019-07-17 | Becton Dickinson & Co. | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| 2019-07-17 | Becton Dickinson & Co. | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| 2019-07-17 | Becton Dickinson & Co. | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| 2019-07-17 | Becton Dickinson & Co. | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| 2017-10-27 | Roche Molecular Systems, Inc. | The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the coloni |
| 2016-07-18 | Cepheid | Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations. |
| 2014-07-23 | Becton Dickinson & Co. | The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tes |
| 2012-05-22 | Becton Dickinson & Co. | Leakage in Cepheid SmartCycler reaction tubes. |
| 2011-11-17 | Cepheid | Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (b |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.