Recall Z-0743-2013 ยท CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Alfa Wassermann, Inc.
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.
| Date | Jan 28, 2013 (initiated Oct 10, 2012) |
| Status | Terminated |
| Reason | Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 4,104 kits |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD Alfa Wassermann Diagnostic Technologies, Inc., Sep 8, 2011 |