Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Software Version 2.8 & Below on VITROS 5 Recalled by Ortho-Clinical Diagnostics Due to Software Anomaly; It is possible for the device...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho-Clinical Diagnostics directly.
Affected Products
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.
Quantity: VITROS 5.1 System: Domestic - 909; Foreign - 1250; 5,1 Refurbished: Domestic - 66 units, Foreign - 152
Why Was This Recalled?
Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay).
Where Was This Sold?
Worldwide Distribution -- USA, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics has 185 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report