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Gbs Culture Media, Selective And Differential

FDA product code PQZ · Class 1 · Microbiology

6
Registered devices
4
Adverse events
3
Recalls
4
510(k) clearances

Devices with this code

N/A — HARDY DIAGNOSTICSStrep B Carrot Broth™ — HARDY DIAGNOSTICSStrep B Carrot Broth™ — HARDY DIAGNOSTICSCarrot Broth™ — HARDY DIAGNOSTICSchromID® Strepto B agar — BIOMERIEUX SAN/A — HARDY DIAGNOSTICS

Recent recalls

DateFirmReason
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2020-10-06Hardy DiagnosticsStreptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of
2020-04-20Cardinal Health Inc.Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.