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Z-1530-2014 Class II Terminated

Recalled by Alfa Wassermann, Inc. — West Caldwell, NJ

FDA device recall Z-1530-2014 was initiated by Alfa Wassermann, Inc. on March 5, 2014 and is designated Class II. Reason for recall: Extremely low absorbance readings. The recall status is terminated (terminated August 13, 2015). Affected quantity: SA1047 lot F3609: 146; RX1047 lot F3610: 53.

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)