Devices

Device Recall PROTrac II Tacrolimus ELISA kit

Model / Serial
131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
Product Description
DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. || Product Usage: || The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
Manufacturer
Diasorin Inc.
1 Event
- Recall of Device Recall PROTrac II Tacrolimus ELISA kit

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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