Class 2 Device Recall A1CNOW

• Date Initiated by Firm: August 31, 2007
• Create Date: June 25, 2015
• Recall Status: Terminated on March 25, 2008
• Recall Number: Z-0289-2008
• Recall Event ID: 44752
• 510(K)Number: K051321
• Product Classification: Glycosylated Hemoglobin Assay - Product Code LCP
• Product: A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care.
• Code Information: Model Number 03022-Lot Numbers 0707812, 0707813, 0707814, and 0707815.
• Recalling Firm/ Manufacturer: Metrika Inc; 510 Oakmead Pkwy; Sunnyvale CA 94085-4022
• For Additional Information Contact: 408-524-2255 Ext. 290
• Manufacturer Reason for Recall: Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.
• FDA Determined Cause: Process control
• Action: A September 14, 2007, Urgent Device Recall letter was issued to all Distribution Center Managers to return recalled product for replacement. Customer notification was made via a Dear Healthcare Professional letter dated Sept. 14, 2007, also titled Urgent Medical Device Recall.
• Quantity in Commerce: 4,286
• Distribution: Nationwide including states of AK, AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, MA, MD, MI, MN, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LCP