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Whole Blood Primer
BIO-RAD LABORATORIES, INC. · Model 270-0351 · UDI-DI 00847817010606
3
510(k) clearances
0
Adverse events
5
Recalls
6
Facilities
Description
Whole Blood Primer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-04-08 | Bio-Rad Laboratories, Inc. | There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used. |
| 2011-05-25 | Tosoh Bioscience Inc | The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The |
| 2010-08-18 | Tosoh Bioscience Inc | The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quan |
| 2008-03-18 | Bio-Rad Laboratories Inc | Some product ROM cards have an incorrect program loaded and are unable to be updated. |
| 2008-03-18 | Bio-Rad Laboratories Inc | Some product ROM cards have an incorrect program loaded and are unable to be updated. |
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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.