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.
데이터 추가 비고
Glycosylated Hemoglobin Assay - Product Code LCP
원인
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.
조치
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.
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.
제품 설명
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.