Device Recall ABBOTT TestPackPlus Strep A with On Board Controls (OBC) II

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