Reported Jan 24, 2018 · Terminated

Phadia 1000 Instrument, Article Number 12-3800-01.

Phadia US 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: Phadia US Inc · 4169 Commercial Ave · Portage, MI · 49002-9701

Is this the product you have?

    • Phadia 1000 Instrument
    • Article Number 12-3800-01
Lot codes and dates
  • All versions of the instrument
Amount recalled
70 units

Where it was sold

  • Nationwide

Why it was recalled

The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 4, 2018 · Data as of Sep 19, 6:18 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.