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Cal-Chex
STRECK, INC. · Model 221101 · UDI-DI 20844509000246
10
510(k) clearances
21
Adverse events
2
Recalls
20
Facilities
Description
A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 1 vial.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-04 | Siemens Healthcare Diagnostics, Inc. | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. |
| 2011-10-25 | Bio-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.
Get your free API keyRead the docsData 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.
