Reported Apr 29, 2015 · Terminated

DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit…

Diasorin Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Diasorin Inc. · 1951 Northwestern Ave S · Stillwater, MN · 55082-7536

Is this the product you have?

  • DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN
  • Product UsageThe 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
Lot codes and dates
    • 131716
    • 131716A
    • 131716B
    • 131716C
    • 131716D
    • 131716E
    • 131717
Amount recalled
451 kits

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Diasorin Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 15, 2015 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.