Abbott Laboratories HPD/ADD/GPRD

list 3C10-10, lots 94165M100 and 94164M100

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and internationally to Guatemala, Venezuela, Peru, Argentina, Dominican Republic, Canada, Japan, Singapore, Thailand, Korea, Australia, Costa Rica, Panama and Great Britain.

IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng/mL, Calibrator E having 20 ng/mL and Calibrator F having 30 U/mL; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

List 5C63-16 [20 test kit lots]: 04671M300, 10138M200, 10139M200, 10140M200, 10141M200, 10142M200, 10143M200, 12224M100, 12225M100, 12792M200, 12794M200, 13063M200, 13066M200, 13165M200, 13166M200, 13167M200, 13168M200, 13725M100, 13921M100, 14153M100, 14154M100, 14898M200, 14906M200, 14908M200 and 14911M200.    List 5C63-21 [40 test kit lots]: 10148M200, 10149M200, 10150M200, 10151M200, 10152M200, 12796M200, 12129M200, 12222M100, 12223M100, 13064M200, 13065M200, 13162M200, 13163M200, 13164M200, 13925M100, 14146M100, 14147M100, 14148M100 and 14149M100.

Immunology and Microbiology Devices

1

No

The product was not distributed in the U.S. The product was distributed internationally through Abbott affiliates in Argentina, Korea, the United kingdom, Japan, Singapore, the Dominican Republic, Canada, Hong Kong, Chile and Germany

ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA

lot numbers 10264M300, 10264M301, 10265M300, and 10265M301

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, Taiwan, Australia, New Zealand, Thailand, China and Korea.

AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

lot numbers 07747M100 and 07747M101

Immunology and Microbiology Devices

2

No

Canada, Australia, Germany and Japan

ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.

list 9116-65, lots 04111M200, 10239M200, 10060M200, 10060M201

Clinical Chemistry and Clinical Toxicology Devices

2

No

There was no domestic distribution. The product was distributed internationally through Abbott subsidiaries in Canada, United Kingdom, Japan, Singapore, Hong Kong, Korea, Australia, New Zealand, Honduras, Costa Rica, Panama, Dominican Republic, Germany and Pakistan.

TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064