FDA Recall
Terminated
Instructions 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.
Recall: Z-2282-2016
·
Initiated June 7, 2016
Recall
- Recall Number
- Z-2282-2016
- Event Number
- 74452
- Firm
- Tosoh Bioscience, Inc.
- FEI Number
- 1000123732
- Product Code
- JIT
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- June 7, 2016
- Posted
- July 25, 2016
- Terminated
- February 22, 2017
- Address
- 6000 Shoreline Ct, Ste 101, South San Francisco, CA, 94080-7606
Description
Instructions 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.
Reason
Instructions For Use had incorrect lot number and calibrator values
Action
Tosoh 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.
Distribution
US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Quantity
41 single sets of Progesterone 3 calibrators