Recall Z-3030-2011 ยท JPD Hemoglobin A2 Quantitation
Tosoh Bioscience Inc
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.
| Date | Aug 17, 2011 (initiated May 25, 2011) |
| Status | Terminated |
| Reason | 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%. |
| Root cause | Process control |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE Tosoh Medics, Inc., May 14, 2002 |