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Terminated

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 Laboratories, Abbott Park, IL 600064 U.S.A.

FDA Recall Z-0783-05 · Posted 2005-04-28

Recalling FirmAbbott Laboratories MPG
Recall StatusTerminated
Product CodeCGN
Date Initiated2005-03-11
Date Terminated2006-01-18
Product Quantity2,521 kits

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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