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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