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 |
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