Device product
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST 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 laboratories.
Z-1530-2014
Product summary
- Event
- Event 67897
- Status
- Terminated
- Classification
- Class II
- Quantity
- SA1047 lot F3609: 146; RX1047 lot F3610: 53
- Official record key
device-enforcement:Z-1530-2014
Official wording
Reason: Extremely low absorbance readings.
Code information: ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Extremely low absorbance readings.