Home › Device types › JPD
Hemoglobin A2 Quantitation
FDA product code JPD · Class 2 · Hematology
21
Registered devices
0
Adverse events
5
Recalls
13
510(k) clearances
Devices with this code
VARIANT II B-thalassemia — BIO-RAD LABORATORIES, INC.Whole Blood Primer — BIO-RAD LABORATORIES, INC.Sickle-Thal Quik Column Kit — HELENA LABORATORIES CORPORATIONVARIANT II / VARIANT II TURBO — BIO-RAD LABORATORIES, INC.D-10 — BIO-RAD LABORATORIES, INC.Beta-Thal HbA2 Quik Column Kit — HELENA LABORATORIES CORPORATIOND-10 Dual — BIO-RAD LABORATORIES, INC.D-10 — BIO-RAD LABORATORIES, INC.D-10 Dual — BIO-RAD LABORATORIES, INC.VARIANT II B-thalassemia — BIO-RAD LABORATORIES, INC.TSKgel G7 β-Thal. HSi — TOSOH CORPORATIONVARIANT II B-thalassemia — BIO-RAD LABORATORIES, INC.D-10 Dual — BIO-RAD LABORATORIES, INC.Hemoglobin F&A2 Control Set — TOSOH CORPORATIONVARIANT II B-thalassemia — BIO-RAD LABORATORIES, INC.Hemoglobin F&A2 Calibrator — TOSOH CORPORATIOND-10 Dual — BIO-RAD LABORATORIES, INC.VARIANT II B-thalassemia — BIO-RAD LABORATORIES, INC.VARIANT II B-thalassemia — BIO-RAD LABORATORIES, INC.G7 Beta-Thalassemia Elution Buffer Kit — TOSOH CORPORATIONVARIANT II B-thalassemia — BIO-RAD LABORATORIES, INC.
Recent 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 |
| 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 |
| 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 repor |
| 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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