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.
FDA Recall Z-3030-2011 · Posted 2011-08-17
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Recalling FirmTosoh Bioscience Inc
Recall StatusTerminated
Product CodeJPD
Date Initiated2011-05-25
Date Terminated2012-02-24
Product Quantity6 boxes/4/2 mL btls
Reason for Recall
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 criteria of the value is +/- 0.3%.
Firm Action
TOSOH Bioscience sent an "Urgent Recall Notification" letter dated July, 25, 2011 to all affected customers.
The letter described the problem and asks customers to immediately discontinue use of the product and return all remaining product back to the firm. Customers can contact TOSOH for replacement.
For additional information or question on this recall please contact TOSOH Technical Support at (800) 248-6769.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution: Nationwide (USA) distribution including the states of FL and IL; and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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