Ortho-Clinical VITROS XT 7600 System Recalled for Potential Sample Dispensing Errors
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated Systems because sample fluid may be dispensed to incorrect positions, potentially causing erroneous assay results.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with significant injury or property damage reports, or in this case, a structural/functional defect in a diagnostic device that could lead to erroneous clinical results.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS XT 7600 Integrated System, a medical device intended for in vitro diagnostic use. The recall involves 85 units distributed worldwide, including 19 units in the United States and 66 units in foreign countries. The affected units are identified by serial numbers 76000108 through current and are equipped with V3.4 or 3.4.1 software.
The recall is being conducted because there is a potential for sample fluid to be dispensed to an incorrect position on the MicroSlide. This malfunction could lead to erroneous assay results being reported. The agency has classified this recall as Class II, indicating a situation where use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Healthcare facilities and users of the VITROS XT 7600 Integrated System should contact Ortho-Clinical Diagnostics for instructions on how to proceed. The source text does not specify a particular action for end-users beyond the recall notification, but standard procedure for medical device recalls typically involves stopping use and contacting the manufacturer or regulatory authority for guidance on repair, replacement, or return.
The recalled product
- Product
- VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
- Manufacturer
- Ortho-Clinical Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number 76000108 thru current.
Distribution
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