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EHR

BIOMERIEUX SA · Model 70520 · UDI-DI 03573026099862

JTO Prescription
10
510(k) clearances
211
Adverse events
21
Recalls
27
Facilities

Description

EHR is a reagent associated to API 20 A® (20 300)

Recalls

DateFirmReason
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed

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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.