Reported Mar 13, 2024 · Ongoing
VITROS XT 3400 Chemistry System, Catalog No. 6844458
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 3400 Chemistry SystemCatalog No. 6844458
- Lot codes and dates
- VITROS System Software Versions 3.8.0 or 3.8.1
- UDI-DI 10758750031986 Serial NumbersUS:
J34500140J34500180J34500257J34500289J34500319J34500386J34500422J34500447J34500473J34500474J34500510J34500539J34500547J34500579J34500588J34500622J34500656J34500777J34500818J34500861J34500887J34500893
- J34500896 J34500911 J34500931 OUS
J34500123J34500128J34500129J34500130J34500190J34500261J34500269J34500271J34500292J34500301J34500337J34500356J34500363J34500515J34500520J34500536J34500582J34500609J34500628J34500658J34500711J34500793J34500802J34500940J34500960J34500962
- Amount recalled
- 25 US; 26 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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