Date Initiated by Firm |
October 10, 2012 |
Date Posted |
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
|
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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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