Recall Z-2282-2016
Tosoh Bioscience, Inc. · initiated June 7, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)
Reason for recall
Instructions For Use had incorrect lot number and calibrator values
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-2282-2016
- Initiated
- June 7, 2016
- Posted by FDA
- July 25, 2016
- Terminated
- February 22, 2017
- Product code
- JIT – Calibrator, Secondary
- Quantity
- 41 single sets of Progesterone 3 calibrators
- Distribution
- US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
- Recalling firm
- Tosoh Bioscience, Inc., South San Francisco, CA