Recall Z-1530-2014

Alfa Wassermann, Inc. · initiated March 5, 2014

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)

Reason for recall

Extremely low absorbance readings.

FDA-determined cause: Process control

Action taken

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).

Details

Recall number
Z-1530-2014
Initiated
March 5, 2014
Posted by FDA
April 30, 2014
Terminated
August 13, 2015
Product code
CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot
Quantity
SA1047 lot F3609: 146; RX1047 lot F3610: 53
Distribution
US Nationwide Distribution
Recalling firm
Alfa Wassermann, Inc., West Caldwell, NJ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1529-2014 Class IIAlfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For…Extremely low absorbance readings. 03/05/2014Terminated