Recall Z-0131-2015 ยท CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Abbott Laboratories, Inc
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
| Date | Oct 28, 2014 (initiated Apr 7, 2014) |
| Status | Terminated |
| Reason | Package inserts have incorrect SmartWash parameters for Triglyceride. |
| Root cause | Labeling Change Control |
| Action | 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 produc |
| Quantity | 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, Columbia, Croatia, Czech Republic, Dominican Republic, Egypt, Estonia, France, Germany, Greece, Guat |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.