Reported Mar 13, 2024 · Ongoing
VITROS 5600 Integrated System (New and 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 5600 Integrated System (New and Refurbished)
- Lot codes and dates
- UDI/DI
(New) 10758750002740(Refurbished) 10758750007110
- Serial NumbersJ56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691 and J36001164 through J36001692 (inclusive)
- UDI/DI
- Amount recalled
- 1460 units (506 US, 954 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
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
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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