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Cfas HbA1c
Roche Diagnostics GmbH · Model 4528417190 · UDI-DI 04015630921096
KRZ
Prescription
1
510(k) clearances
21
Adverse events
2
Recalls
20
Facilities
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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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.