Events

Recall of Device Recall A1CNOW

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Metrika Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    44752
  • Event Risk Class
    Class 2
  • Event Number
    Z-0289-2008
  • Event Initiated Date
    2007-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64351
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Glycosylated Hemoglobin Assay - Product Code LCP
  • Reason
    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.
  • 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.

Device

Device Recall A1CNOW
  • Model / Serial
    Model Number 03022-Lot Numbers 0707812, 0707813, 0707814, and 0707815.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Metrika Inc

Manufacturer

Metrika Inc
  • Manufacturer Address
    Metrika Inc, 510 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • Source
    USFDA