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BECKMAN COULTER IRELAND INC. · Model OSR6163 · UDI-DI 15099590010607

DEM Prescription
1
510(k) clearances
5
Adverse events
1
Recalls
23
Facilities

Description

α-1 ANTITRYPSIN

Recalls

DateFirmReason
2017-08-23The Binding Site Group, Ltd.The high control for the kit is recovering low and may be out of range for assigned values.

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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.