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.
This recall has been terminated (originally issued January 28, 2013).
- Company
- Alfa Wassermann, Inc.
- Recall Initiated
- October 10, 2012
- Posted
- January 28, 2013
- Terminated
- October 25, 2013
- Recall Number
- Z-0743-2013
- Quantity
- 4,104 kits
- Firm Location
- Caldwell, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
Lot / Code Info
Lot Number 155599
Root Cause
Device Design
Action Taken
Alfa Wassermann sent an important advisory notice/product response form to their distributors on October 10, 2012. The letter identified the product, the problem, and the action to be taken by the customer. The letter informs customers about the affected lot and provide instruction regarding the receipt of replacement product. Any recalled product should be destroyed. If there is further distribution, those customers should provide Alfa with a distribution list so that they may be notified. Any questions can be directed to (866) 419 - 2532.