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Diasorin Inc. recalls DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA ki
Recalled April 29, 2015 · FDA recall Z-1464-2015 · Diasorin
Hazard
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. · FDA Class II
Units
451 kits
Sold at
Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
Description
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Product
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(s)
Diasorin Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →