Xpert®
CEPHEID · Model SWAB/G-50-US · UDI-DI 07332940008345
10
510(k) clearances
26
Adverse events
3
Recalls
8
Facilities
Description
Swab Specimen Collection Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-07-17 | Becton Dickinson & Co. | The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. |
| 2018-09-24 | Becton Dickinson & Co. | A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vagin |
| 2018-09-24 | Becton Dickinson & Co. | A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vagin |
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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.