Recall Z-3030-2011
Tosoh Bioscience Inc · initiated May 25, 2011
Product
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.
Codes / lots: Part Number 020019. Lot # BCAL05R. Used By Date 2011-10.
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%.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-3030-2011
- Initiated
- May 25, 2011
- Posted by FDA
- August 17, 2011
- Terminated
- February 24, 2012
- Product code
- JPD – Hemoglobin A2 Quantitation
- Quantity
- 6 boxes/4/2 mL btls
- Distribution
- Worldwide Distribution: Nationwide (USA) distribution including the states of FL and IL; and the country of Canada.
- Recalling firm
- Tosoh Bioscience Inc, Grove City, OH