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CELL-DYN

ABBOTT LABORATORIES · Model 09H70-01 · UDI-DI 00380740020347

KRZ Prescription
10
510(k) clearances
21
Adverse events
2
Recalls
18
Facilities

Description

CELL-DYN 18 PLUS CALIBRATOR

Recalls

DateFirmReason
2025-06-04Siemens Healthcare Diagnostics, Inc.Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
2011-10-25Bio-Rad Laboratories, Inc.It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.

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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.