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U.S. Department of Health and Human Services

Class 3 Device Recall AIAPACK TPOAb CONTROL SET

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  Class 3 Device Recall AIAPACK TPOAb CONTROL SET see related information
Date Initiated by Firm February 08, 2017
Date Posted May 15, 2017
Recall Status1 Terminated 3 on February 08, 2019
Recall Number Z-2168-2017
Recall Event ID 76659
510(K)Number K981521  
Product Classification System, test, thyroid autoantibody - Product Code JZO
Product AIA-PACK TPOAb CONTROL SET
Code Information TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017
Recalling Firm/
Manufacturer		 Tosoh Bioscience, Inc.
6000 Shoreline Ct Ste 101
South San Francisco CA 94080-7606
For Additional Information Contact Mrs. Susan H. Koss
614-317-1909
Manufacturer Reason
for Recall		 The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
FDA Determined
Cause 2		 Labeling mix-ups
Action On 3/3/2017 the firm sent recall notificaion letters to their customers.
Quantity in Commerce 15 boxes
Distribution Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
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 = JZO and Original Applicant = TOSOH MEDICS, INC.
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