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JAMES 70542Recalls & reported problems

Biomerieux SA · JAMES is a reagent associated to API® NH, API 20 ETM, API® 10 S, RapiD 20 ETM, API® 20 NE, RAPIDEC® ur, ID 32 E), rapid ID 32 A, rapid ID 32 E · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Nov 9, 2022Open, Classified

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

    Z-0810-2023 · Root cause: Storage · FDA record ↗

Other DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION devices

All DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.