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U.S. Department of Health and Human Services

Class 3 Device Recall ST AIAPACK PROG III Calibrator Set

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 Class 3 Device Recall ST AIAPACK PROG III Calibrator Setsee related information
Date Initiated by FirmJune 07, 2016
Date PostedJuly 25, 2016
Recall Status1 Terminated 3 on February 22, 2017
Recall NumberZ-2282-2016
Recall Event ID 74452
510(K)NumberK153417 
Product Classification Calibrator, secondary - Product Code JIT
ProductInstructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
Code Information Catalog Number 02534001 (One set of Calibrators US)  Lot G13C303 (only those received/repackaged in the US)
Recalling Firm/
Manufacturer		 Tosoh Bioscience, Inc.
6000 Shoreline Ct Ste 101
South San Francisco CA 94080-7606
For Additional Information ContactSusan H. Koss
614-317-1909
Manufacturer Reason
for Recall		Instructions For Use had incorrect lot number and calibrator values
FDA Determined
Cause 2		Error in labeling
ActionTosoh Bioscience sent an Urgent Correction Notification letter dated June 7, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Tosoh Technical Support at 1-800-248-6764.
Quantity in Commerce41 single sets of Progesterone 3 calibrators
DistributionUS Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JIT
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