Recall Z-0289-2008 ยท LCP Assay, Glycosylated Hemoglobin
Metrika Inc
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
| Date | Aug 31, 2007 |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051321 | INVIEW Metrika, Inc., Jun 13, 2005 |