Recall Z-1233-2007 ยท LDP Colorimetry, Acetaminophen
Abbott Laboratories Inc.
MULTIGENT Acetaminophen, List Number 2K99-20
| Date | Sep 18, 2007 (initiated Jun 1, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042330 | ACETAMINOPHEN-SL ASSAY Diagnostic Chemicals , Ltd., Jan 7, 2005 |