Recall Z-0743-2013— Alfa Wassermann, Inc.

Name: FDA recall Z-0743-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-10

Class II · Terminated

Class II FDA medical device recall by Alfa Wassermann, Inc., initiated 2012-10-10, terminated 2013-10-25. It names one FDA 510(k) clearance: K103615. Product: 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: Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results..

Recalling firm: Alfa Wassermann, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-10
Terminated: 2013-10-25
Firm location: W Caldwell, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K103615 — ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARDAlfa Wassermann Diagnostic Technologies, Inc.·cleared 2011-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.