Laboratory Diagnostic System Software Defects Cause System Freezes and Result Delays
The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.
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: FDA Class II recall of a diagnostic system where software defects could delay critical test results. No injuries or illnesses have been reported, making this a theoretical-harm scenario, which caps severity at High (3) per the rubric for risk-of-harm products without reported illness.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS 5600 integrated laboratory analyzer systems (Product Codes 6802413 and refurbished 6802915) running Software Version 3.8.0. The software defects cause unresponsive subsystems, frozen user interface screens, and printer disconnections. When these issues occur, system shutdown and restart are required to recover functionality, resulting in delays to test result reporting.
The delayed result reporting is of concern for critical or STAT assays where rapid test availability is necessary for patient treatment decisions. A total of 176 units have been identified and distributed nationwide in the US and globally.
Because the software version could not be updated automatically, affected facilities required on-site visits from Ortho-Clinical field engineers to manually install the corrected software. Customers should verify they have received the software update from their equipment representative.
The recalled product
- Product
- VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 176
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 (4)
- Product Code: 6802413
- UDI-DI: 10758750002740
- Product Code: 6802915
- UDI-DI: 10758750007110
Distribution
Distributed nationwide across the United States.
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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