Reported Mar 13, 2024 · Ongoing
VITROS XT 7600 Integrated System, Catalog No. 6844461
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 XT 7600 Integrated SystemCatalog No. 6844461
- Lot codes and dates
- VITROS System Software Version 3.8.1
- UDI-DI 10758750031610 Serial Numbers US
J76000199J76001383J76000207J76001385J76000353J76001392J76000456J76001404J76000459J76001406J76000460J76001516J76000468J76001518J76000495J76001519J76000502J76001520J76000561J76001581J76001207J76001583J76001230J76001611J76001231J76001620J76001232J76001644J76001235J76001647J76001239J76001660J76001260J76001668J76001263J76001671J76001270J76001674J76001274J76001692J76001331
- J76001700 J76001351 J76001748 OUS
J76000118J76001070J76000253J76001074J76000265J76001095J76000274J76001121J76000281J76001130J76000370J76001152J76000447J76001174J76000475J76001328J76000620J76001377J76000855J76001378J76000856J76001396J76000898J76001399J76000901J76001407J76000973J76001408J76000976J76001484J76001001J76001673J76001027J76001761J76001035
- Amount recalled
- 44 US; 35 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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