FDAClass IIFebruary 6, 2013

Alfa Wassermann System Diluent recall

Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa…

Why was Alfa Wassermann System Diluent recalled?

Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 155599

Product
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa…
Recalling firm
Alfa Wassermann, Inc.
Quantity
4,104 kits
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
Recall date
February 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls