ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c (EZA1c) Calibrat

FDA device recall Z-0482-2009 · posted 2008-12-17 · Terminated

Recall details

Recalling firm

Alfa Wassermann, Inc.

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

LCP

Quantity affected

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.

Date initiated

2008-08-22

Date posted

2008-12-17

Date terminated

2009-04-15

Location

Caldwell, NJ

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