Z-0681-03

IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along...

Name: Z-0681-03 IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along...
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 IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott... on 2003-03-04. The reason FDA records is "The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens". 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-0681-03
Status: Terminated
Initiated: 2003-03-04
Posted: 2003-03-26
Terminated: 2004-09-15
Recalling firm: Abbott Medical
Product: IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL
Product code: MOI System, Test, Immunological, Antigen, Tumor
Reason for recall: The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recalled by letter dated 3/4/03. The accounts were informed of the depressed values for the CA 15-3 High Control and for patient specimens, and were requested to discontinue use and destroy any of the three affected lots found in inventory.
Quantity in commerce: 409 packs
Distribution: Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
Product codes and lots: list 6A75-22, lot 90843M200

Product code MOI

K964407Class IIImx Ca 15-3Abbott Laboratories / cleared 1997-11-10

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)