Class II — Diasorin Inc.
| Recalling firm | DiaSorin Inc. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. |
| 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. |
| Quantity | 451 kits |
| Distribution | Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA. |
| Initiated | 2015-03-16 |
| Classified | 2015-04-20 |
| Terminated | 2015-09-15 |
| Recall number | Z-1464-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Diasorin Inc. (Z-1464-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70773/
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