Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Software Error
Ortho-Clinical Diagnostics is recalling 80 VITROS XT 7600 Integrated Systems because a software error may cause incorrect test results without alerting the user.
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 risk-of-harm product (medical device) where incorrect results could lead to patient harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 80 units of the VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658. The affected systems are running software versions 3.4 and 3.4.1. The recall is due to a software defect where an algorithm designed to detect sample dispense errors was inadvertently disabled.
Because of this defect, sample dispense errors may lead to incorrect results being reported without an error code to alert the user. The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest.
The products were distributed worldwide, including in the United States (AZ, CA, FL, IL, OH, TX, and VA) and in foreign countries such as Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, and the United Kingdom. Users should contact Ortho-Clinical Diagnostics for instructions on how to address the software issue.
The recalled product
- Product
- VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using…
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 80
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)
- Systems Running Software Version 3.4 & 3.4.1
Distribution
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