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U.S. Department of Health and Human Services

Class 2 Device Recall Lipase Reagent

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  Class 2 Device Recall Lipase Reagent see related information
Date Initiated by Firm April 07, 2014
Date Posted October 28, 2014
Recall Status1 Terminated 3 on April 01, 2015
Recall Number Z-0131-2015
Recall Event ID 67987
Product Classification Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
Product Lipase Reagent, 7D80.

Used to measure lipase in human serum on the Architect system.
Code Information lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11.
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Dr
Irving TX 75038-4313
For Additional Information Contact
877-422-2688
Manufacturer Reason
for Recall		 Package inserts have incorrect SmartWash parameters for Triglyceride.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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, Guatemala, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turks and Caicos, Turkey, Uganda, United Arab Emirates, United Kingdom, and Uruguay.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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