Recalling Firm / Manufacturer

Abbott Laboratories Inc.

Product

Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30

Code Information

List Numbers: 7D80-20 and 7D80-30; Control Numbers: 37033HW00, 33032HW00, 30053HW00, 47048HW00, 45067HW00, 43002HW00, 42016HW00 & 42010HW00

Reason of Recall

Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.

Date Recall Initiated

June 01, 2007

Action

The firm initiated the recall on 06/01/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions for modification to the SmartWash feature in the Lipase Assay Configuration in order to prevent Acetaminophen from contaminating Lipase. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.