Events

Recall of Device Recall ACE AST Reagent Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alfa Wassermann, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67897
  • Event Risk Class
    Class 2
  • Event Number
    Z-1530-2014
  • Event Initiated Date
    2014-03-05
  • Event Date Posted
    2014-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126580
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Nadh oxidation/nad reduction, ast/sgot - Product Code CIT
  • Reason
    Extremely low absorbance readings.
  • 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).

Device

Device Recall ACE AST Reagent Kits
  • Model / Serial
    ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. || Product Usage: For quantitative determination of AST 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 laboratories.
  • Manufacturer
    Alfa Wassermann, Inc.

Manufacturer

Alfa Wassermann, Inc.
  • Manufacturer Address
    Alfa Wassermann, Inc., 4 Henderson Dr, West Caldwell NJ 07006-6608
  • Manufacturer Parent Company (2017)
    Alfa Wassermann Inc
  • Source
    USFDA