Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0781-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeNIG
Date Initiated2004-03-23
Date Terminated2005-04-26
Product Quantity1,987 kits

Reason for Recall

The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.

Firm Action

Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers.

Root Cause

Other

Distribution Pattern

Canada, Australia, Germany and Japan

Official Source

View FDA Recall →

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

↑