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VARIANT II Hemoglobin A1c
BIO-RAD LABORATORIES, INC. · Model 270-2115NU · UDI-DI 00847817011979
1
510(k) clearances
21
Adverse events
2
Recalls
18
Facilities
Description
VARIANT II Hemoglobin A1c Program Calibrator/Diluent Set
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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