Devices

Device Recall Hemoglobin F & A2 Calibrator.

Model / Serial
Part Number 020019. Lot # BCAL05R. Used By Date 2011-10.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: Nationwide (USA) distribution including the states of FL and IL; and the country of Canada.
Product Description
Hemoglobin F & A2 Calibrator, || 0.2 mL, 4 brown glass vials/box. || Mfr. By: Tosoh Bioscience, || Minato-ku, Tokyo, Japan. || Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-thalassemia testing on the Tosoh G7.
Manufacturer
Tosoh Bioscience Inc
1 Event
- Recall of Device Recall Hemoglobin F & A2 Calibrator.

Manufacturer

Tosoh Bioscience Inc

Manufacturer Address
Tosoh Bioscience Inc, 3600 Gantz Road, Grove City OH 43123
Source
USFDA

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