Abbott Laboratories MPG 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Abbott Laboratories MPG
Lot Codes / Batch Numbers
list 9C08-10, lot number 29506M100, expiration date July 5, 2006
Products Sold
list 9C08-10; lot number 29506M100, expiration date July 5, 2006
Abbott Laboratories MPG is recalling CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagent due to The CA 15-3 Controls replicates out of range high resulting in invalid runs.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The CA 15-3 Controls replicates out of range high resulting in invalid runs.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026