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 Versions 3.8.0 or 3.8.1
- UDI-DI 10758750031610 Serial NumbersUS:
139 of 139 codes
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
- J76001553 J76001879 J76000873 OUS
78 of 78 codes
J76000106J76000976J76000118J76000983J76000211J76001001J76000253J76001027J76000257J76001035J76000265J76001070J76000274J76001074J76000276J76001095J76000278J76001111J76000280J76001121J76000281J76001130J76000284J76001141J76000288J76001142J76000289J76001144J76000290J76001152J76000292J76001155J76000293J76001159J76000370J76001174J76000436J76001183J76000446J76001189J76000447J76001272J76000475J76001273J76000620J76001285J76000628J76001309J76000760J76001314J76000782J76001328J76000807J76001368J76000813J76001377J76000838J76001378J76000845J76001379
- Amount recalled
- 142 US; 78 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
- Nationwide
Why it was recalled
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which 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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