Device Recall ST AIAPACK PROG III Calibrator Set

Catalog Number 02534001 (One set of Calibrators US)  Lot G13C303 (only those received/repackaged in the US)

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.

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.