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Terminated

Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott park, IL 60064

FDA Recall Z-0726-03 · Posted 2003-04-16

Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeLOJ
Date Initiated2003-03-04
Date Terminated2003-09-04
Product Quantity107 kits

Reason for Recall

The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values

Firm Action

Recalled by letter dated 3/4/03. The laboratory accounts were informed of the lot of calibrators causing depressed values for the IMx AFP Low Control, requested to destroy any of the suspect lot of calibrators, and recalibrate the AFP assay using a different lot of calibrators.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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