Devices

Device Recall DiaSorin Lp(a) diluent

Model / Serial
Lp(a) Diluent - 60 mL bottles Catalog #23817, Lot #s 238017-01 & 238017-03; catalog # 95046B, Lot # 238017-02. DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,113656, 113656A, and 113656B
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
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
Product Description
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 .
Manufacturer
Diasorin Inc.
1 Event
- Recall of Device Recall DiaSorin Lp(a) diluent

Manufacturer

Diasorin Inc.

Manufacturer Address
Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
Manufacturer Parent Company (2017)
DiaSorin SpA
Source
USFDA

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