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 PO2 electrodes are affected.

Clinical Chemistry and Clinical Toxicology Devices

United States

PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.

List no. 3B34-20

Clinical Chemistry and Clinical Toxicology Devices

Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama

AxSYM Tricyclic Antidpressants Reagent. Distributied under the following label: || AxSYM || Abbott Laboratories USA, North Chicago, IL 60064

List no. 9681-55

Clinical Chemistry and Clinical Toxicology Devices

Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama

ADx Tricyclic Antidepressants Reagent. || Distributed under the following label: || ADx, Abbott Laboratories USA, North Chicago, IL 60064

List no. 9681-60

Clinical Chemistry and Clinical Toxicology Devices

Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama

TDx/TDxFLx || TDx/TDxFLX Tricyclic Antidepressant Reagent || Distributed under the following label: || TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064

T3606, Exp 31 Mar 2004

Clinical Chemistry and Clinical Toxicology Devices

Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).

CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****

Lot 5003, Exp. 12 September 2003

Clinical Chemistry and Clinical Toxicology Devices

Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.

Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793

All fielded instruments.

Clinical Chemistry and Clinical Toxicology Devices

Nationwide and Canada

Access 2 Immunoassay System

All fielded instruments.

Clinical Chemistry and Clinical Toxicology Devices

Nationwide and Canada

Access 2 immunoassay side of LXi 725

Lot 86027HW00, Exp Date May 14, 2003 Lot 89150HW00, Exp Date September 13, 2003

Clinical Chemistry and Clinical Toxicology Devices

Nationwide and to Mexico, Colombia, Canada, Brazil, Ecuador, Hong Kong, New Zealand, Germany, Dominican Republic, El Salvador, Venezuela, Bahamas, Argentina, Puerto Rico.

Aeroset Direct HDL Reagent, LN 7D67-01

Lot #204016, Exp 09 NOV 02

Clinical Chemistry and Clinical Toxicology Devices

The kits were shipped to one (1) consignee located in California.

Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050.

All units with current software versions (v 06-06 and 07-01).

Clinical Chemistry and Clinical Toxicology Devices

United States

Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.

serial numbers 168252 through 169574.

Clinical Chemistry and Clinical Toxicology Devices

United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.

Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed.]

All units.

Clinical Chemistry and Clinical Toxicology Devices

United States.

Roche brand Cardiac Reader.

All units.

Clinical Chemistry and Clinical Toxicology Devices

Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.

Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN; Ref/No. 03112276180; Part number BP5016.

All units.

Clinical Chemistry and Clinical Toxicology Devices

Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.

Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112349180, Part number BP5186.

All units.

Clinical Chemistry and Clinical Toxicology Devices

Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.

Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112314018, Part number BP5032.

All units.

Clinical Chemistry and Clinical Toxicology Devices

Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.

Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA system only, Manufacturer part number T01-3606-01, Mfd for Bayer Corporation, 511 Benedict Ave, Tarrytown, NY., Roche part number 03361322001.

All units.

Clinical Chemistry and Clinical Toxicology Devices

Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.

Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.

All units. (Sold only outside of the U.S. by Sysmex in Japan.)

Clinical Chemistry and Clinical Toxicology Devices

Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.

AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte analyzer, Roche part number 03112357182.

All units. (Sold only outside of the U.S. by Vital in Netherlands).

Clinical Chemistry and Clinical Toxicology Devices

Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.

Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.

Lot Numbers: 618609

Clinical Chemistry and Clinical Toxicology Devices

Nationwide Distribution.

DBS MICROPLATE, TRUNCATED V-BOTTOMED || Product Number: 3033-0010

Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175

Clinical Chemistry and Clinical Toxicology Devices

Nationwide Distribution.

Microplate, truncated V-bottomed lots included in the || above listed products || Product Number: 1380 5465. || DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.

all serial numbers

Clinical Chemistry and Clinical Toxicology Devices

Worldwide Distribution - USA nationwide including PR and the country of Guam.

Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: || 03111873180 as a part of the following systems: || 1. 03337103001, cobas b 221<1>Roche OMNI S1 system || 2. 03337111001, cobas b 221<2>Roche OMNI S2 system || 3. 03337154001,cobas b 221<6>Roche OMNI S6 system || 4. 03337138001, cobas b 221<4>Roche OMNI S4 system || Product Usage: Usage: || Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin

Catalog Number 365992 Lot numbers: 6139630, 6213209, 6296815 and 7059245

Clinical Chemistry and Clinical Toxicology Devices

Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia

BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ