ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott

FDA device recall Z-0783-05 · posted 2005-04-28 · Terminated

Recall details

Recalling firm

Abbott Laboratories MPG

Reason for recall

concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert.

Action taken

Abbott international affilates were notified of the recall by e-mail on 03/11/2005, and requested to notifiy their customers. The letters inform the end users of the downward shift in control and/or patient results, and requested them to assess their normal and deficient ranges for their specific population, assess their quality control ranges and follow their laboratory procedures for reviewing patient results and notifying Health Care Providers that they serve. There was no U.S. distribution.

Root cause

Other

Status

Terminated

Product code

CGN

Quantity affected

2,521 kits

Distribution

Canada, Singapore, New Zealand, Germany, Hong Kong, Japan, and Australia

Date initiated

2005-03-11

Date posted

2005-04-28

Date terminated

2006-01-18

Location

Abbott Park, IL