Reported Mar 13, 2024 · Ongoing
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (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 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
- Lot codes and dates
- VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002979 Refurbished
- UD-DI 10758750007103 Serial NumbersUS: J36000109 J36000292 J36000489 J36000955 J36001167 J36001222
- J36001283 J36001330 J36001348 OUS
66 of 66 codes
J36000148J36001000J36001495J36000340J36001012J36001513J36000348J36001024J36001515J36000406J36001026J36001519J36000407J36001027J36001528J36000427J36001051J36001530J36000446J36001088J36001535J36000511J36001108J36001558J36000517J36001111J36001570J36000580J36001112J36001573J36000612J36001117J36001575J36000626J36001154J36001579J36000688J36001229J36001581J36000753J36001237J36001582J36000861J36001245J36001583J36000877J36001246J36001595J36000920J36001401J36001600J36000923J36001403J36001602J36000929J36001427J36001608J36000933J36001451J36001618
- Amount recalled
- 9 US; 66 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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