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.
This recall has been terminated (originally issued July 25, 2016).
- Company
- Tosoh Bioscience, Inc.
- Recall Initiated
- June 7, 2016
- Posted
- July 25, 2016
- Terminated
- February 22, 2017
- Recall Number
- Z-2282-2016
- Quantity
- 41 single sets of Progesterone 3 calibrators
- Firm Location
- South San Francisco, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Instructions For Use had incorrect lot number and calibrator values
Distribution
US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Lot / Code Info
Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)
Root 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.
More recalls by Tosoh Bioscience, Inc.
AIA-PACK TPOAb CONTROL SET
May 15, 2017
AIA-PACK TgAb CONTROL SET
May 15, 2017