DiaSorin — Class II medical device recall Z-1464-2015
Terminated recall by Diasorin Inc., reported 2015-04-29, distributed in CA. Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
| Recall number | Z-1464-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diasorin Inc., Stillwater, MN, United States |
| Recall initiated | 2015-03-16 |
| Classified | 2015-04-20 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2015-09-15 |
| Distributed | CA |
| Countries outside the US | AR, BE, CN, IN |
| Quantity | 451 kits |
| Model numbers | 32400, 32400-CN |
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 for recall
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1464-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.