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TRYPTOSE BLOOD AGAR BASE

OXOID LIMITED · Model CM0233B · UDI-DI 05032384002115

JSG
10
510(k) clearances
879
Adverse events
29
Recalls
65
Facilities

Recalls

DateFirmReason
2025-04-24Mckesson Medical-Surgical Inc. Corporate Officetransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur
2021-02-16Vectornate USA IncDiscoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
2019-04-17Remel IncPotential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t
2019-04-17Remel IncPotential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t
2019-04-17Remel IncPotential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t
2019-04-17Remel IncPotential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t
2019-04-17Remel IncPotential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months t
2019-04-17Remel IncPotential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t
2019-04-17Remel IncPotential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t
2019-04-17Remel IncPotential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months t

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Data 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.