Ortho VITROS XT3400 Chemistry System Recalled for Erroneous Results
Ortho Clinical Diagnostics is recalling VITROS XT3400 Chemistry Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves erroneous test results from a medical device, which poses a risk of harm to patient care, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho Clinical Diagnostics is recalling the VITROS XT3400 Chemistry System, Product code 6844458. The recall involves specific units with serial numbers J34500122 and J34500231.
The recall is due to a defect where MicroSlides utilizing Slot 18 in the CM rotor may be mis-positioned during processing. This mis-positioning can result in certain VITROS MicroSlides producing erroneous results.
The affected products were distributed worldwide, including in the United States and various international markets such as Australia, Belgium, Brazil, Canada, and the United Kingdom. Users of the VITROS XT3400 Chemistry System should check their equipment serial numbers against the affected list and contact Ortho Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS XT3400 Chemistry System, Product code 6844458
- Manufacturer
- Ortho Clinical Diagnostics
- Hazard
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 numbers J34500122 J34500231
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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