FDAFDA · Food and drugs·Recall number Z-0743-2013
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.
Published February 6, 2013 · Recall initiated: October 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alfa Wassermann, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
- Lot
- Lot Number 155599
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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