Reported Jan 20, 2016 · Terminated
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product…
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 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD
- Product UsageFor use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
- Lot codes and dates
Software Version 3.2 and belowSerial Numbers J36000012 - 36000879
- Amount recalled
- Domestic: 200, Foreign: 554
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
Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.
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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