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

FDA device recall Z-1244-06 · posted 2006-07-18 · Terminated

Recall details

Recalling firm

Abbott Laboratories MPG

Reason for recall

The CA 15-3 Controls replicates out of range high resulting in invalid runs.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MOI

Quantity affected

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.

Date initiated

2006-06-09

Date posted

2006-07-18

Date terminated

2008-01-18

Location

Abbott Park, IL

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