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.
FDA Recall Z-0743-2013 · Posted 2013-01-28
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Recalling FirmAlfa Wassermann, Inc.
Recall StatusTerminated
Product CodeCEO
Date Initiated2012-10-10
Date Terminated2013-10-25
Product Quantity4,104 kits
Reason for Recall
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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