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Beckman Coulter, Inc. · Model OSR6152 · UDI-DI 15099590010492

DDD Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
1
Facilities

Description

Transferrin

Recalls

DateFirmReason
2023-09-06Beckman Coulter Biomedical DivisionThe firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneo

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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.