Z-1464-2015Class II

DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN

Name: Z-1464-2015 DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN
Creator: Diasorin Inc.
Published: 2015-03-16
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2015-03-16 / Terminated

FDA source

Diasorin Inc. began a 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 reagent system intended... on 2015-03-16. FDA classified it as Class II and gives the reason as "Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1464-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-16
Posted: 2015-04-20
Terminated: 2015-09-15
Recalling firm: Diasorin Inc.
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.
Product code: MLM Enzyme Immunoassay, Tracrolimus
Reason for recall: Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
FDA 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 in commerce: 451 kits
Distribution: Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
Product codes and lots: 131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1464-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1464-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-20

Product code MLM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)