Z-0726-03

Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for...

Name: Z-0726-03 Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for...
Creator: Abbott Laboratories HPD/ADD
Published: 2003-03-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-03-04 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories HPD/ADD began a recall of 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... on 2003-03-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0726-03
Status: Terminated
Initiated: 2003-03-04
Posted: 2003-04-16
Terminated: 2003-09-04
Recalling firm: Abbott Medical
Product: 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
Product code: LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
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
Root cause tag: manufacturing process
FDA root cause: Other
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.
Quantity in commerce: 107 kits
Distribution: Nationwide
Product codes and lots: lot number 89651M300, exp. 04/20/03

Product code LOJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)