Z-1529-2014Class II

Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent

Name: Z-1529-2014 Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent
Creator: Alfa Wassermann, Inc.
Published: 2014-03-05
License: https://open.fda.gov/license/

Alfa Wassermann / initiated 2014-03-05 / Terminated / root cause: manufacturing process

FDA source

Alfa Wassermann, Inc. began a recall of Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using... on 2014-03-05. FDA classified it as Class II and gives the reason as "Extremely low absorbance readings". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1529-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Posted: 2014-04-30
Terminated: 2015-08-13
Recalling firm: Alfa Wassermann
Product: Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.
Product code: CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Reason for recall: Extremely low absorbance readings.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Alfa Wassermann Diagnostic Technologies, LLC issued an "Important: Advisory Notice/"Product Response Form" dated March 5, 2014 and sent on March 6, 2014 to their customers for ACE ALT Reagent Product reorder number SA1046 Lot F3604. They issued a follow-up "Important: Advisory Notice/"Product Response Form" dated March 21, 2014 and sent on March 26, 2014 to their customers for ACE AST Reagent Product reorder numbers SA1047, Lot F3609, and RX1047, Lot F3610. The notification identified the product(s), problem, and actions to be taken by the customers. Customers were instructed to destroy any affected product and complete and submit the enclosed Product Response Form. For questions or concerns, contact the Alfa Wassermann Diagnostic Technologies, LLC Customer Solution Center, Toll Free: (866) 419-ALFA (2532).
Quantity in commerce: 731 Kits
Distribution: US Nationwide Distribution
Product codes and lots: ACE¿ ALT Reagent (Product reorder number SA1046 Lot F3604)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1529-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1529-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-29
Z-1530-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-29

Product code CKA

K131351Class IIAce Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC / cleared 2013-08-15

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)