Tosoh Bioscience, Inc.

TgAb: G644899 Expires June 2017; G844801 Expires August 2017 & GX44802 Expires 09/30/2017.

Immunology and Microbiology Devices

2

No

Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.

AIA-PACK TgAb CONTROL SET

TPOAb: G644783 Expires June 2017 & G844784 Expires August 2017

Immunology and Microbiology Devices

2

No

Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.

AIA-PACK TPOAb CONTROL SET

All active analyzers

Hematology and Pathology Devices

2

No

Worldwide distribution. The products were shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, AND WY. The recalled products were shipped to the following countries: Brazil, Chile, Columbia, Guatemala, Costa Rica, Dominican Republic, Eduador, Nicaragua, Panama, Peru, Puerto Rico, Uruguay,

Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

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.

Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015

Hematology and Pathology Devices

2

No

Us Nationwide Distribution in the state ID including PR.

G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. || Product Usage: || G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.