Reported Feb 15, 2017 · Terminated

VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein…

Ortho-Clinical Diagnostics

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: Ortho-Clinical Diagnostics · 513 Technology Blvd · Rochester, NY · 14626-3601

Is this the product you have?

  • VITROS Chemistry Products UPRO Slides, UPN 10758750000593
  • Product UsageQuantitative measurement of total protein concentration in urine
Lot codes and dates
  • Product Code REF 680 0120 LotGENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018
Amount recalled
37,571 packs/90 slides totalling 3,381,390 slides

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.

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.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 22, 2018 · Data as of Sep 19, 4:46 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.