Gbs Culture Media, Selective And Differential
Microbiology · 21 CFR 866.2360
Culture Medium for GBS Detection
Recent MDR events
4 adverse event reports on file
- CHROMID® STREPTO B AGARJun 18, 2018MalfunctionBiomerieux Sa3002769706-2018-00079
- CHROMID® STRB AGARMar 2, 2018MalfunctionBiomerieux Sa3002769706-2018-00025
- CHROMID STREPTO B AGARNov 1, 2017MalfunctionBiomerieux Sa3002769706-2017-00326
- CHROMID STREPTO B AGARNov 1, 2017MalfunctionBiomerieux Sa3002769706-2017-00327
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0847-2023 · View FDA record ↗ - Hardy DiagnosticsTerminatedUnknown
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10
Z-0441-2021 · View FDA record ↗ - Cardinal Health Inc.TerminatedUnknown
Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen coll
Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Z-2051-2020 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
4 clearances for this product code