Reported Oct 26, 2016 · Terminated
VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier…
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 · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.
- Lot codes and dates
Current/In-date GENs 2627282931
- Amount recalled
- US: 18,749 sales units; Foreign: 94,928 sales units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.
This product could cause temporary or reversible health problems — stop using it.
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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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