VITROS 5600 Diagnostic System Software Defect May Cause Erroneous Lab Results
A software defect in VITROS 5600 Systems prevents quality control baseline statistics from updating properly, which may cause erroneous patient test results to be reported.
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—a software defect that may cause incorrect lab results—which fits the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The VITROS 5600 Integrated System is a laboratory diagnostic analyzer used in clinical settings to process patient samples and generate test results. Ortho-Clinical Diagnostics has issued a recall of specific units running Software Version 3.8.1 due to a software defect.
The defect affects quality control (QC) baseline statistics. When users attempt to update these statistics, the system fails to apply the changes as expected. This malfunction may result in the system reporting erroneous—that is, incorrect—patient test results.
No illnesses or injuries have been reported. The affected units are distributed worldwide, including multiple US states (AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV) and countries including Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
Users of affected units should contact Ortho-Clinical Diagnostics for software updates or replacement instructions.
The recalled product
- Product
- VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Ortho-Clinical Diagnostics, Inc. 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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