Diasorin Inc.: Medical Device Recall in 2015 - (Recall #: Z-1464-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 16, 2015

Date Posted: April 29, 2015

Recall Number: Z-1464-2015

Event ID: 70773

Reason for Recall:

Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.

Status: Terminated

Product Quantity: 451 kits

Code Information:

131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717.

Distribution Pattern:

Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.

Voluntary or Mandated:

Voluntary: Firm initiated