Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall A1CNOW

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall A1CNOW see related information
Date Initiated by Firm August 31, 2007
Create Date June 25, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = METRIKA, INC.
-
-