Date Initiated by Firm | May 25, 2011 |
Date Posted | August 17, 2011 |
Recall Status1 |
Terminated 3 on February 24, 2012 |
Recall Number | Z-3030-2011 |
Recall Event ID |
59488 |
510(K)Number | K020489 |
Product Classification |
Hemoglobin A2 Quantitation - Product Code JPD
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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. |
Code Information |
Part Number 020019. Lot # BCAL05R. Used By Date 2011-10. |
Recalling Firm/ Manufacturer |
Tosoh Bioscience Inc 3600 Gantz Road Grove City OH 43123
|
For Additional Information Contact | Susan (NMI) Koss 614-317-1909 |
Manufacturer 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 2 | 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 in Commerce | 6 boxes/4/2 mL btls |
Distribution | Worldwide Distribution: Nationwide (USA) distribution including the states of FL and IL; and the country of Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JPD
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