All lots.

Clinical Chemistry and Clinical Toxicology Devices

USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 || The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay

All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - U.S. Nationwide - Latin America

Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. || Product Usage: || The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK C-Peptide; Part Number: 025284 || Assay, Diabetes

All lots.

Clinical Chemistry and Clinical Toxicology Devices

1

No

USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 || The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.

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

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 II, Progesterone II Assay, Part Number: 025239

AIA-900 19tray Sorter with S/N 10000109 to S/N 80136909. AIA-900 9tray Sorter with S/N 10000109 to S/N 10707402.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - U.S. Nationwide - Latin America

Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. || Product Usage: || The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.

The following lots numbers are affected by this recall:   060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay.

AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag || AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK HGH; Part Number: 025266 || Assay, Metabolic

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK Testosterone; Part Number: 025204 || Assay, Reproductive Hormone

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK SHBG; Part Number: 025238 || Assay, Reproductive Hormone

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK Prog II; Part Number: 025239 || Assay, Reproductive Hormone

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK LH II; Part Number: 025296 || Assay, Reproductive Hormone

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK hsE2; Part Number: 025225 || Assay, Reproductive Hormone

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK Estradiol; Part Number: 025274 || Assay, Reproductive Hormone

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK Prolactin; Part Number: 025255 || Assay, Reproductive Hormone

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK FSH; Part Number: 025265 || Assay, Reproductive Hormone

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA DHEA-S; Part Number: 025222 || Assay, Reproductive Hormone

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK IRI; Part Number: 025260 || Assay, Diabetes

All Lot Codes

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

ST-AIA PACK C-Peptide II; Part Number: 025283 || Assay, Diabetes

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.

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.

All G8's with Reporting Software interfaced with LIS.

Immunology and Microbiology Devices

2

No

US Nationwide Distribution in the states of CT, MA, ME, MN, MO, NC, NE, NH, PA, SD, TX, VA, & WV.

Keyspan High-High Speed USB to Serial Adapter || Product Usage: || The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port. The default for the firmware is dynamic which randomly assigns a port for the transmission of data. The port assignment can change when the power for the analyzer or computer is shut down or the cable is physically disconnected and then reconnected. The default can be changed to geographic which allows the port assignment to be static regardless of a power outage.

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