Reported Mar 16, 2016 · Terminated
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. 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 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD
- Product UsageFor in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
- Lot codes and dates
Software Version 3.2 and belowSerial Numbers J46000001 - 46000678
- Amount recalled
- US = 163; Foreign = 286
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
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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