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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 Device Recall Alfa Wassermann System Diluent 750 mL see related information
Date Initiated by Firm October 10, 2012
Date Posting Updated January 28, 2013
Recall Status1 Terminated 3 on October 25, 2013
Recall Number Z-0743-2013
Recall Event ID 63866
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 NJ 07006-6608
For Additional Information Contact
866-419-2532
Manufacturer Reason
for Recall
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
FDA Determined
Cause 2
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CEO and Original Applicant = ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
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