Reported Jul 8, 2020 · Terminated
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
Ortho Clinical Diagnostics
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 · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS 3600 Immunodiagnostic
- System - Refurbished Product Code6802914
- Unique Identifier10758750007103
- Lot codes and dates
- Affected Serial Number
360001923600039636000430360004313600044636000468360005043600051736000577360005803600058536000631360006473600036636000267360003863600040436000420360005623600061436000575360005893600048036000582360006873600049236001042
- Affected Serial Number
- Amount recalled
- 27 ( U.S.= 0; OUS= 27)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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