Z-0319-04

IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064

Name: Z-0319-04 IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-11-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-11-25 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064 on 2003-11-25. The reason FDA records is "The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0319-04
Status: Terminated
Initiated: 2003-11-25
Posted: 2004-01-10
Terminated: 2004-07-26
Recalling firm: Abbott Medical
Product: IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064
Product code: LTK--
Reason for recall: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Field Correction recall by letter dated 11/25/03 to all customers receiving the affected reagents. The accounts were informed of the incorrect control package insert referenced in the product information letter shipped with each CA 125 product. The letters contained the correct control package insert number, 34-1047/R4, and stated that all CA 125 assay product inserts will be updated shortly to include the revised storage instructions for the CA 125 Calibrators and Controls.
Distribution: Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica, Japan, Korea, New Zealand, Pakistan, Puerto Rico, Singapore, Taiwan, Thailand, United Kingdom and Uruguay.
Product codes and lots: all lots

Product code LTK--

K964185Class IIImx Ca 125Abbott Diagnostics / cleared 1997-11-04

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)