Z-1464-2015 Class II Terminated
FDA device recall Z-1464-2015 was initiated by Diasorin Inc. on March 16, 2015 and is designated Class II. Reason for recall: Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. The recall status is terminated (terminated September 15, 2015). Affected quantity: 451 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2015
- Initiation Date
- March 16, 2015
- Termination Date
- September 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 451 kits
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.
Reason for Recall
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Distribution Pattern
Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
Code Information
131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717.