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U.S. Department of Health and Human Services

Class 3 Device Recall Hemoglobin F & A2 Calibrator.

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  Class 3 Device Recall Hemoglobin F & A2 Calibrator. see related information
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
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
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.
510(K) Database 510(K)s with Product Code = JPD and Original Applicant = TOSOH MEDICS, INC.
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