FDA Recalls VITROS 4600 Chemistry System for Software-Related Freezes
Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.
What this means for you
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 where no illnesses or injuries have been reported. However, the software defect in a clinical laboratory analyzer poses a recognized risk of patient harm by potentially delaying critical test results. Per the rubric, this qualifies as a high-severity recall because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling 51 units of the VITROS 4600 Chemistry System (Product Code 6802445 and refurbished Product Code 6900440) running Software Version 3.8.0. The recall was initiated after post-release monitoring identified an increased occurrence of software-related issues.
The identified problems include unresponsive subsystems, unresponsive user interface (sometimes referred to as screen freeze), and printer disconnections. These issues would cause a delay in reporting test results due to required system shutdowns needed to recover the system. Such delays could occur during any assay, including tests where speed is critical or designated as STAT, and could result in delayed patient treatment.
The affected systems were manufactured with an installation requirement—users could not update the software themselves but required a field engineer to manually install the update on each affected unit. The affected serial numbers are specific to the product codes and UDI-DI identifiers listed by FDA.
Affected facilities should contact their VITROS system representative or Ortho-Clinical Diagnostics for guidance on software updates and any necessary corrective actions. Healthcare providers should verify their systems' software version and take appropriate steps to ensure result reporting capabilities are functioning properly.
The recalled product
- Product
- VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 51
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: 6802445
- UDI-DI: 10758750012343
- Product Code: 6900440
- UDI-DI: 10758750033201
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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