Recall Z-0636-05 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Diasorin Inc.
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 .
| Date | Mar 18, 2005 (initiated Jan 10, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 631 as individual vials, 1 bulk unit and 401 sold in kits |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982708 | SPQ TEST SYSTEM DiaSorin, Inc., Apr 2, 1999 |