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Calibrator For Hemoglobin And Hematocrit Measurement

FDA product code KRZ · Class 2 · Hematology

24

Registered devices

21

Adverse events

2

Recalls

25

510(k) clearances

Devices with this code

Cal-Chex — STRECK, INC.ADVIA® 360/560 Calibrator — Siemens Healthcare Diagnostics Inc.Cal-Chex A Plus — STRECK, INC.CDS Hematology Calibrator — CLINICAL DIAGNOSTIC SOLUTIONS, INC.Cal-Chex — STRECK, INC.CDS Hematology Calibrator — CLINICAL DIAGNOSTIC SOLUTIONS, INC.Cal-Chex A Plus — STRECK, INC.VARIANT II TURBO — BIO-RAD LABORATORIES, INC.VARIANT II TURBO — BIO-RAD LABORATORIES, INC.Atellica HEMA Calibrator — Siemens Healthcare Diagnostics Inc.CELL-DYN — ABBOTT LABORATORIES VARIANT II TURBO Link — BIO-RAD LABORATORIES, INC.VARIANT II Hemoglobin A1c — BIO-RAD LABORATORIES, INC.ADVIA® 120/2120/2120i SETpoint — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIES VARIANT II Hemoglobin A1c — BIO-RAD LABORATORIES, INC.Cal-Chex A Plus — STRECK, INC.CELL-DYN — ABBOTT LABORATORIES Boule Cal — CLINICAL DIAGNOSTIC SOLUTIONS, INC.VARIANT II TURBO — BIO-RAD LABORATORIES, INC.Alinity — Abbott GmbH ARCHITECT — ABBOTT LABORATORIES Cfas HbA1c — Roche Diagnostics GmbH ARCHITECT — ABBOTT LABORATORIES

Recent 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.