Recall Z-2282-2016 ยท JIT Calibrator, Secondary
Tosoh Bioscience, Inc.
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.
| Date | Jul 25, 2016 (initiated Jun 7, 2016) |
| Status | Terminated |
| Reason | Instructions For Use had incorrect lot number and calibrator values |
| Root cause | Error in labeling |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153417 | ST AIA-PACK PROG III Calibrator Set Tosoh Bioscience, Inc., Dec 18, 2015 |