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U.S. Department of Health and Human Services

Class 2 Device Recall Alfa Wassermann System Diluent 750 mL

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 Class 2 Recall
Alfa Wassermann System Diluent 750 mL
see related information
Date Posted January 28, 2013
Recall Status1 Terminated on October 25, 2013
Recall Number Z-0743-2013
Recall Event ID 63866
Premarket Notification
510(K) Number
K103615 
Product Classification Phosphomolybdate (Colorimetric), Inorganic Phosphorus - Product Code CEO
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.
Code Information Lot Number 155599
Recalling Firm/
Manufacturer
Alfa Wassermann, Inc.
4 Henderson Dr
W Caldwell, New Jersey 07006-6608
Manufacturer Reason
for Recall
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
FDA Determined
Cause 2
DESIGN: 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 in Commerce 4,104 kits
Distribution Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CEO and Original Applicant = ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
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