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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

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.
Recall Number Z-0743-2013
Classification Class II
Code Info Lot Number 155599
Product Distributed Qty 4,104 kits
Reason For Recall Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

Event Detail

Event Id 63866
Product Type Devices
Status Ongoing
Recalling Firm Alfa Wassermann, Inc.
City W Caldwell
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands