CLASS II Device recall · Reported 15 Feb 2017 · FDA Enforcement Report

Vitros Chemistry Products Upro Slides, Upn recalled

Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Upro Slides, Upn 10758750000593, distributed nationwide in the US. The recall was initiated on 8 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code REF 680 0120 Lot: GENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018

Quantity recalled37,571 packs/90 slides totalling 3,381,390 slides

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1179-2017
FDA event ID: 75936
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 8 Dec 2016
FDA classified: 9 Feb 2017
Reported: 15 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Dec 2016	Recall initiated by company
9 Feb 2017	Classified by FDA	+63 days
15 Feb 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

Where it was distributed

Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Product Code REF 680 0120 Lot: GENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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