Device 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.
Z-1464-2015
Product summary
- Firm
- Diasorin Inc.
- Event
- Event 70773
- Status
- Terminated
- Classification
- Class II
- Quantity
- 451 kits
- Official record key
device-enforcement:Z-1464-2015
Official wording
Reason: Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
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.
Derived failure modes
-
Unknown
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.