Home / Recalls / Alfa Wassermann, Inc. / Z-1529-2014

Z-1529-2014 Class II Terminated

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

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: 731 Kits

Product Description

Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT 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 labs.

Reason for Recall

Extremely low absorbance readings.

Distribution Pattern

US Nationwide Distribution

Code Information

ACE¿ ALT Reagent (Product reorder number SA1046 Lot F3604)