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Trinity Biotech
PRIMUS CORPORATION · Model A2+F Control Material Kit · UDI-DI 05391516744409
JCM
Prescription
10
510(k) clearances
2
Adverse events
1
Recalls
5
Facilities
Description
Hemoglobin variants assay, A2+F Control Material Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-07 | Tosoh Bioscience, Inc. | The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at th |
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