Recall Z-1232-2007
Abbott Laboratories Inc. · initiated June 1, 2007
Product
Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30
Codes / lots: List Numbers: 7D80-20 and 7D80-30; Control Numbers: 37033HW00, 33032HW00, 30053HW00, 47048HW00, 45067HW00, 43002HW00, 42016HW00 & 42010HW00
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: 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.
Details
- Recall number
- Z-1232-2007
- Initiated
- June 1, 2007
- Posted by FDA
- September 18, 2007
- Terminated
- April 5, 2012
- Product code
- CHI – Lipase-Esterase, Enzymatic, Photometric, Lipase
- Quantity
- 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.
- Recalling firm
- Abbott Laboratories Inc., South Pasadena, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1233-2007 | MULTIGENT Acetaminophen, List Number 2K99-20Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a… | 06/01/2007Terminated |