Device Recall TDx/TDxFLX

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

Reagent List 9515-60, lot 03492Q100 and Reagent List 9515-85, lot 04530Q100 that contain insert item number 69-5121/R4

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.

Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

Reagent List 9512-60,lots 06313Q100, 01368Q101, 95380Q100, 93579Q100, 90107Q100; and Reagent List 9512-85, lots 06312Q100, 02010Q100, 96606Q100, 95106Q100, 90108Q100 that contain insert item numbers 34-1074/R3 or 69-5120/R2

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.

Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

Reagent List 9500-60, lots 03136Q100, 92723Q102, 92723Q101, 92723Q100; and Reagent List 9500-85, lots 02285Q100, 92724Q100 that contain insert item number 69-5162/R4

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.

Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number 69-5162/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

Reagent List 9523-60, lots 05105Q100, 03122Q100, 01649Q101, 01649Q100, 01179Q102, 01179Q101, 01179Q100;and Reagent List 9523-85, lots 05576Q100, 01742Q100, 96817Q100, 92749Q100 that contain insert item number 69-5726/R4

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.

Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064