Z-0743-2013Class II

Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4...

Name: Z-0743-2013 Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4...
Creator: Alfa Wassermann, Inc.
Published: 2012-10-10
License: https://open.fda.gov/license/

Alfa Wassermann / initiated 2012-10-10 / Terminated / root cause: design

FDA source

Alfa Wassermann, Inc. began a recall of Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann... on 2012-10-10. FDA classified it as Class II and gives the reason as "Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0743-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-10
Posted: 2013-01-28
Terminated: 2013-10-25
Recalling firm: Alfa Wassermann
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.
Product code: CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Reason for recall: Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Lot Number 155599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0743-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0743-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-28

Product code CEO

K103615Class IIAce Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus u.v. Reagent,urine StandardAlfa Wassermann Diagnostic Technologies, Inc. / cleared 2011-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)