Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Ab

FDA device recall Z-1498-04 · posted 2004-09-30 · Terminated

Recall details

Recalling firm

Abbott Laboratories HPD/ADD/GPRD

Reason for recall

There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.

Action taken

Abbott affiliates in Canada, Germany, Australia, New Zealand, England and Japan were e-mailed copies of the recall letter on 8/27/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for significant differences in quantitative results for certain specimens and were instructed to discontinue use and destroy any of the affected lots remaining.

Root cause

Other

Status

Terminated

Product code

LOM

Quantity affected

6,691 kits

Distribution

Canada, Japan, Australia, New Zealand, Germany and England

Date initiated

2004-08-27

Date posted

2004-09-30

Date terminated

2005-07-29

Location

Abbott Park, IL