MULTIGENT Acetaminophen, List Number 2K99-20
FDA device recall Z-1233-2007 · posted 2007-09-18 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDP
- Quantity affected
- 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, Thail
- Date initiated
- 2007-06-01
- Date posted
- 2007-09-18
- Date terminated
- 2012-04-05
- Location
- South Pasadena, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACETAMINOPHEN-SL ASSAY (K042330) | Diagnostic Chemicals , Ltd. | 2005-01-07 |