Events

Recall of Device Recall ACE EZA1c Reagent, Glycosylated hemoglobin assay.

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
    49563
  • Event Risk Class
    Class 2
  • Event Number
    Z-0482-2009
  • Event Initiated Date
    2008-08-22
  • Event Date Posted
    2008-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73815
  • 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
    Glycosylated Hemoglobin Assay - Product Code LCP
  • Reason
    Internal studies observed occasional unexpected outlier results in whole blood samples tested for hemoglobin a1c using the eza1c reagent on the ace or ace alera clinical chemistry systems.
  • Action
    An initial URGENT: CUSTOMER ADVISORY NOTICE dated August 22, 2008 was sent to all customers and distributors. The letter stated the problem and asked customers to cease using the EZA1C reagent, controls and calibrators. Customers were asked to hold any affected inventory while additional testing was conducted by Alfa Wassermann Diagnostic Technologies, LLC. (AWDT). A second communication, URGENT: CUSTOMER ADVISORY NOTICE (and Product Response Form) dated September 18, 2008 was sent instructing customers to destroy all product and package inserts in stock for the EZA1C products listed in the letter. Information was provided on receiving credit and an alternative product for use. Customers are requested to complete and return the Product Response Form by fax (888-646-2535) to AWDT indicating their receipt of the letter and the amount of product destroyed. Distributors' letters requested their customers be notified of the recall and that the Product Response Form be sent directly to AWDT. Direct questions to AWDT Customer Solution Center at 866-419-2532.

Device

Device Recall ACE EZA1c Reagent, Glycosylated hemoglobin assay.
  • Model / Serial
    EZA1c Reagent ACI-30, Lot # F2481, Exp. 9/2008 and EZA1c Reagent ACI-30, Lot # F2603, Exp 01/2009. The following EZA1c control and calibrator kits were included in the customer notification instructing them to discard the product. There is no use for these products without the reagent. (EZA1c Controls C2-82, Lot # HBC00507-1, Exp. 10/2008 and EZA1c Calibrators S2-82, Lot # HBS00907-1, Exp. 10/2008).
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. || Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitro diagnostic use only. || Alfa Wassermann Diagnostic Technologies, LLC., || 4 Henderson Drive, || West Caldwell, NJ 07006. || ACE EZA1c Reagent is intended for the quantitative determination of stable hemoglobin A1c in human whole blood samples using the ACE and Ace Alera clinical chemistry systems. Measurement of hemoglobin A1c is a viable indicator for long-term diabetic control.
  • Manufacturer
    Alfa Wassermann, Inc.

Manufacturer

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