Device Recall ST AIAPACK PROG II

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.

All lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.

ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240