Home / Recalls / Alfa Wassermann, Inc. / Z-0743-2013

Z-0743-2013 Class II Terminated

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

Recall Details

Product Type: Devices
Report Date: February 6, 2013
Initiation Date: October 10, 2012
Termination Date: October 25, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,104 kits

Product Description

Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.

Reason for Recall

Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands

Code Information

Lot Number 155599