Z-0743-2013 Class II Terminated
FDA device recall Z-0743-2013 was initiated by Alfa Wassermann, Inc. on October 10, 2012 and is designated Class II. Reason for recall: Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results. The recall status is terminated (terminated October 25, 2013). Affected quantity: 4,104 kits.
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