Device product
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.
Z-1529-2014
Product summary
- Event
- Event 67897
- Status
- Terminated
- Classification
- Class II
- Quantity
- 731 Kits
- Official record key
device-enforcement:Z-1529-2014
Official wording
Reason: Extremely low absorbance readings.
Code information: ACE¿ ALT Reagent (Product reorder number SA1046 Lot F3604)
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Extremely low absorbance readings.