Recall Z-0482-2009 ยท LCP Assay, Glycosylated Hemoglobin
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
| Date | Dec 17, 2008 (initiated Aug 22, 2008) |
| Status | Terminated |
| 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 |
| Quantity | Reagent Lot F2481 = 264 kits and Reagent Lot F2603 = 69 kits. (Control Lot HBC00507-1=322 kits and Calibrator Lot HBS00 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070734 | MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON Diazyme Laboratories, Apr 9, 2007 |