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GROUP A STREPTOCOCCUS
Hologic, Inc. · Model GROUP A STREP DIRECT TEST (GASD) 500T · UDI-DI 15420045506312
MDK
Prescription
4
510(k) clearances
4
Adverse events (1 deaths)
2
Recalls
0
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-12-30 | Gen-Probe Inc | This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with corr |
| 2007-05-02 | Gen-Probe Inc | Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches |
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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.