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U.S. Department of Health and Human Services

Class 2 Device Recall MULTIGENT Acetaminophen

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  Class 2 Device Recall MULTIGENT Acetaminophen see related information
Date Initiated by Firm June 01, 2007
Date Posted September 18, 2007
Recall Status1 Terminated 3 on April 05, 2012
Recall Number Z-1233-2007
Recall Event ID 38635
510(K)Number K042330  
Product Classification in vitro diagnostic - Product Code LDP
Product MULTIGENT Acetaminophen, List Number 2K99-20
Code Information List Number 2K99-20; Control Numbers: 30455UQ11 & 31046UQ02
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Irene Powers
847-937-1998
Manufacturer Reason
for 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 342
Distribution Worldwide, including USA, Australia, Brazil, Canada, Chile, El Salvador, Dominican Republic, Ecuador, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Thailand, and Venezuela.
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.
510(K) Database 510(K)s with Product Code = LDP and Original Applicant = DIAGNOSTIC CHEMICALS LTD.
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