Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.

FDA device recall Z-0131-2015 · posted 2014-10-28 · Terminated

Recall details

Recalling firm

Abbott Laboratories, Inc

Reason for recall

Package inserts have incorrect SmartWash parameters for Triglyceride.

Action taken

Firm issued a Product Correction Letter to all Lipase reagent customers who received lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11. The letter identified the affected product and provided an explanation of the problem, as well as, the patient impact and actions to be taken. The Product Correction Letter provided guidance for the laboratory to correctly configure the Architect cSystem's Lipase assay parameters. Customers are to retain a copy of the letter for their lab records, and forward a copy to any laboratories that the product was further distributed to. Questions should be directed to Customer Service at 1-877-4ABBOTT or your local customer service for customers outside of the US.

Root cause

Labeling Change Control

Status

Terminated

Product code

CHI

Quantity affected

11916 units

Distribution

Worldwide Distribution: US (nationwide) and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China,

Date initiated

2014-04-07

Date posted

2014-10-28

Date terminated

2015-04-01

Location

Irving, TX