| Class 2 Device Recall Lipase | |
Date Initiated by Firm | June 01, 2007 |
Date Posted | September 18, 2007 |
Recall Status1 |
Terminated 3 on April 05, 2012 |
Recall Number | Z-1232-2007 |
Recall Event ID |
38635 |
Product Classification |
in vitro diagnostic - Product Code CHI
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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 |
Recalling Firm/ Manufacturer |
Abbott Laboratories Inc. 820 Mission St South Pasadena CA 91030-3142
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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.
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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 | 7260 |
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 |
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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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