Z-0482-2009

ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c...

Name: Z-0482-2009 ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c...
Creator: Alfa Wassermann, Inc.
Published: 2008-08-22
License: https://open.fda.gov/license/

Alfa Wassermann / initiated 2008-08-22 / Terminated / root cause: design

FDA source

Alfa Wassermann, Inc. began a recall of ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic... on 2008-08-22. The reason FDA records is "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". 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-0482-2009
Status: Terminated
Initiated: 2008-08-22
Posted: 2008-12-17
Terminated: 2009-04-15
Recalling firm: Alfa Wassermann
Product: 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.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: Reagent Lot F2481 = 264 kits and Reagent Lot F2603 = 69 kits. (Control Lot HBC00507-1=322 kits and Calibrator Lot HBS00907-1=262 kits).
Distribution: Nationwide Distribution.
Product codes and lots: 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 code LCP

K070734Class IIModification to: Direct Enzymatic Hba1c Assay Kit, Model# Dz168a, Dz168a-Cal, Dz168a-ConDiazyme Laboratories / cleared 2007-04-09

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)