Z-0289-2008

A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides...

Name: Z-0289-2008 A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides...
Creator: Metrika Inc
Published: 2007-08-31
License: https://open.fda.gov/license/

Metrika, Inc. / initiated 2007-08-31 / Terminated / root cause: manufacturing process

FDA source

Metrika Inc began a recall of A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of... on 2007-08-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0289-2008
Status: Terminated
Initiated: 2007-08-31
Posted: 2015-06-25
Terminated: 2008-03-25
Recalling firm: Metrika, Inc.
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.
Product code: LCP Assay, Glycosylated Hemoglobin
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Model Number 03022-Lot Numbers 0707812, 0707813, 0707814, and 0707815.

Product code LCP

K051321Class IIInviewMetrika, Inc. / cleared 2005-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)