Device product
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Z-1902-2012
Product summary
- Event
- Event 62017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1600 kits
- Official record key
device-enforcement:Z-1902-2012
Official wording
Reason: Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
Code information: Lot 41928UQ11 {exp 2013-01 -31 )
Distribution pattern: Illinois
Derived failure modes
-
Unknown
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.