Alfa Wassermann, Inc.: 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.

Recall number

Z-0482-2009

Recalling firm

Alfa Wassermann, Inc.

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.

Status

Terminated

Initiated

2008-08-22

Posted

2008-12-17

Terminated

2009-04-15

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.

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

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.

Lot, serial or model codes

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).

510(k) numbers

["K070734"]

PMA numbers

not on file

Product code

LCP

Firm FEI

1000122044

Firm city

Caldwell

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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