Ortho-Clinical Diagnostics, Inc. is recalling 6,337 VITROS 5600, VITROS 4600, and VITROS XT 7600 laboratory testing systems due to a software error. The issue involves how the systems process diluent packs; if a shelf expiration date is not manually entered, the system may treat valid packs as expired, even if safety settings are disabled. This defect was discovered after a customer complaint involving a urine test that was processed with an incorrect expiration code, potentially leading to incorrect or delayed medical results.
The software anomaly can cause the diagnostic systems to report erroneous test results or delay testing entirely. This may impact clinical decisions based on lab data, though no patient injuries have been reported to date.
Includes certified/refurbished systems which maintain original serial numbers.
Quantity includes 1,019 US units and 939 units outside the US.
Includes refurbished systems; total active units in use fluctuates as systems are installed or decommissioned.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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