Recall Z-1464-2015 ยท MLM Enzyme Immunoassay, Tracrolimus
Diasorin Inc.
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.
| Date | Apr 20, 2015 (initiated Mar 16, 2015) |
| Status | Terminated |
| Reason | Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. |
| Root cause | Under Investigation by firm |
| Action | DiaSorin sent a Customer Notification Letter" to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete and return the confirmation form to the manufacturer. For questions contact DiaSorin Inc. Product Support at 1-800-328-1482. |
| Quantity | 451 kits |
| Distribution | Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.