Alfa Wassermann, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0743-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 10, 2012

Date Posted: February 6, 2013

Recall Number: Z-0743-2013

Event ID: 63866

Reason for Recall:

Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

Status: Terminated

Product Quantity: 4,104 kits

Code Information:

Lot Number 155599

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands

Voluntary or Mandated:

Voluntary: Firm initiated