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 . Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AZ, CA, CO, FL, GA, HI, IN, ME, MI, MN, MS, MO, NJ, NY, NC, TX, VA, WI