Reported Mar 16, 2016 · Terminated
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1…
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?
3 of 3 products
| Model / number | Barcodes | Product as published |
|---|---|---|
6801375 | 10758750001132 | VITROS 5,1 FS Chemistry System, , Unique Device Identifier Number 10758750001132 |
6801890 | 10758750001644 | and VITROS 5,1 FS Chemistry System (Refurbished), , Unique Device Identifier Number 10758750001644 |
| — | IVD. Product Usage: The VITROS 5,1 FS 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 2.8 and belowVITROS 51
- FS Chemistry System Serial Numbers
J34000119 - J34002323VITROS 51 FS Chemistry
- System (Refurbished) Serial Numbers
223 of 223 codes
340001333400019334000197340002123400028534000316340003183400033734000360340004203400045134000478340004953400049734000529340005383400055234000557340005903400059634000601340006313400064234000761340007993400080534000833340008513400089334000946340009473400100634001172340012183400124034001243340012483400125134001274340012973400131734001345340013783400137934001389340013903400139634001422340014723400150434001569340015723400161234001626340016333400166834001755340018093400184034001850
- Amount recalled
- US = 994; Foreign = 1405
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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