Z-1530-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2014
- Initiation Date
- March 5, 2014
- Termination Date
- August 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- SA1047 lot F3609: 146; RX1047 lot F3610: 53
Product Description
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.
Reason for Recall
Extremely low absorbance readings.
Distribution Pattern
US Nationwide Distribution
Code Information
ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)