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CELL-DYN

ABBOTT LABORATORIES · Model 08H57-01 · UDI-DI 00380740017071

KRYKRXKSAKRZ Prescription
8
510(k) clearances
7
Adverse events
1
Recalls
16
Facilities

Description

CELL-DYN HemCal Plus Calibrator

Recalls

DateFirmReason
2006-09-18Abbott LaboratoriesPotential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.

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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.