Reported Mar 13, 2024 · Ongoing
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Ortho-Clinical Diagnostics, Inc.
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, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
- Lot codes and dates
- VITROS System Software Version 3.8.1 Regular UDI-DI 10758750012343 Refurbished
- UD-DI 10758750033201 Serial Numbers USJ46000240
- J46000898 J46001030 J46001293 OUS
J46000150J46001041J46000190J46001042J46000499J46001186J46000564J46001187J46000801J46001210J46000821J46001217J46000910J46001289J46000933J46001639J46001029J46001645
- Amount recalled
- 4 US; 18 OUS
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
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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