Z-1244-06

CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents...

Name: Z-1244-06 CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents...
Creator: Abbott Laboratories MPG
Published: 2006-06-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-06-09 / Terminated

FDA source

Abbott Laboratories MPG began a recall of CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles... on 2006-06-09. The reason FDA records is "The CA 15-3 Controls replicates out of range high resulting in invalid runs". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1244-06
Status: Terminated
Initiated: 2006-06-09
Posted: 2006-07-18
Terminated: 2008-01-18
Recalling firm: Abbott Medical
Product: CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values (U/ml): Control L - 35 and Control H - 150; Abbott Laboratories, Abbott Park, IL 60064
Product code: MOI System, Test, Immunological, Antigen, Tumor
Reason for recall: The CA 15-3 Controls replicates out of range high resulting in invalid runs.
FDA root cause: Other
Action: Abbott initiated a field correction recall by letter dated 6/9/06 and sent on 6/12/06 to all customers receiving the affected controls. The accounts were informed of the increase in invalid runs due to controls outside of the package insert range with this lot of CA 15-3 Controls. The accounts were requested to assess the inventory for the affected lot of controls, discontinue use of the lot and destroy the remaining inventory of the lot, recording the number of kits on the customer reply form and faxing it to Abbott by 6/21/06, indicating that the letter was received and understood. Credit will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.
Quantity in commerce: 1794 kits
Distribution: Worldwide, including U.S.A., Puerto Rico, Canada, Mexico, Ecuador, Chile, Argentina, Brazil, Germany, Japan, SIngapore, Hong Kong, Thailand, South Korea and Australia.
Product codes and lots: list 9C08-10; lot number 29506M100, expiration date July 5, 2006

Product code MOI

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)