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
Lipoprotein, Low-Density, Antigen, Antiserum, Control - Product Code DFC
원인
Qc testing of the antibody reagent set for lp(a) spq test system it was discovered that the background was failing high of the specification. through substitution testing it was determined that the lp(a) diluent, part #238017 was the cause of the failing background specification.
조치
Customers were sent notification letters and instructed to destroy any remaining inventory. Customers were also requested to return a form which indicates number of kits destroyed and a replacement was offered.
KC, MO, CA, IN, HI, GA, TX, MN, ME, AZ, FL, VA, MI, NJ, NC, NY, CO, WI, MS, BRUSSELS, GREECE, SWEDEN, ENGLAND, SPAIN, CANADA & SWITZERLAND
제품 설명
Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System .