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.
Recall
- Recall Number
- Z-1530-2014
- Event Number
- 67897
- Firm
- Alfa Wassermann, Inc.
- FEI Number
- 1000122044
- Product Code
- CIT
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 5, 2014
- Posted
- April 30, 2014
- Terminated
- August 13, 2015
- Address
- 4 Henderson Dr, West Caldwell, NJ, 07006-6608
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.
Extremely low absorbance readings.
Alfa Wassermann Diagnostic Technologies, LLC issued an "Important: Advisory Notice/"Product Response Form" dated March 5, 2014 and sent on March 6, 2014 to their customers for ACE ALT Reagent Product reorder number SA1046 Lot F3604. They issued a follow-up "Important: Advisory Notice/"Product Response Form" dated March 21, 2014 and sent on March 26, 2014 to their customers for ACE AST Reagent Product reorder numbers SA1047, Lot F3609, and RX1047, Lot F3610. The notification identified the product(s), problem, and actions to be taken by the customers. Customers were instructed to destroy any affected product and complete and submit the enclosed Product Response Form. For questions or concerns, contact the Alfa Wassermann Diagnostic Technologies, LLC Customer Solution Center, Toll Free: (866) 419-ALFA (2532).
US Nationwide Distribution
SA1047 lot F3609: 146; RX1047 lot F3610: 53