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Beckman Coulter, Inc. · Model OSR6143 · UDI-DI 15099590010409

JHN Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
9
Facilities

Description

APO B

Recalls

DateFirmReason
2025-04-23Beckman Coulter Ireland, Inc.The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B pat

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.