MULTIGENT Acetaminophen, List Number 2K99-20
This recall has been terminated (originally issued September 18, 2007).
- Company
- Abbott Laboratories Inc.
- Recall Initiated
- June 1, 2007
- Posted
- September 18, 2007
- Terminated
- April 5, 2012
- Recall Number
- Z-1233-2007
- Quantity
- 342
- Firm Location
- South Pasadena, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
List Number 2K99-20; Control Numbers: 30455UQ11 & 31046UQ02
Root Cause
Other
Action Taken
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.