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Terminated

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.

FDA Recall Z-1464-2015 · Posted 2015-04-20

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeMLM
Date Initiated2015-03-16
Date Terminated2015-09-15
Product Quantity451 kits

Reason for Recall

Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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