FDA Device recall Z-1464-2015
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 reag…
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of 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 reag… by Diasorin, citing instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1464-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-16 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Diasorin |
| Distribution | CA |
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.
Reason
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Identifiers
| code_info | 131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1464-2015%22
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