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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 mLsee related information
Date Initiated by FirmOctober 10, 2012
Date PostedJanuary 28, 2013
Recall Status1 Terminated 3 on October 25, 2013
Recall NumberZ-0743-2013
Recall Event ID 63866
510(K)NumberK103615 
Product Classification Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
ProductAlfa 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  
FEI Number 1000122044
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
ActionAlfa 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 Commerce4,104 kits
DistributionWorldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CEO
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