Ortho VITROS XT7600 System Recalled for Potential Mis-positioned Slides
Ortho Clinical Diagnostics is recalling VITROS XT7600 Integrated 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 involves a medical device that may produce erroneous results, which poses a risk of harm to patients through incorrect diagnosis or treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS XT7600 Integrated Systems, product code 6844461. The recall affects serial numbers J76000050 through 76000566. The devices were distributed worldwide, including in the United States, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom.
The recall was initiated because MicroSlides utilizing Slot 18 in the CM rotor may be mis-positioned during processing. This mis-positioning can cause certain VITROS MicroSlides to produce erroneous results.
Users of the affected systems should contact Ortho Clinical Diagnostics for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- VITROS XT7600 Integrated System, Product code 6844461
- 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 J76000050 - 76000566
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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