Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.
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: The recall is classified as FDA Class II. The hazard involves a risk of harm (erroneous clinical results) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 4600 Chemistry System, Catalog Number 6802445, with Software Version 3.2 and below. The recall affects serial numbers J46001001 through J4600636. The device is an in vitro diagnostic (IVD) system intended for the quantitative measurement of various analytes of clinical interest.
The recall was initiated due to a software anomaly that may allow the system to sample and process assays while fluids and reagent temperatures are not within the required range for optimal processing. When this intermittent issue occurs, the system continues to operate and process results without notifying the user, which may result in erroneous test outcomes.
The recall covers 157 domestic units and 270 foreign units. Distribution was worldwide, including the United States, Puerto Rico, and numerous foreign countries such as Argentina, Australia, Brazil, Canada, and others. Users of the affected devices should contact Ortho-Clinical Diagnostics for further instructions on how to address the software issue.
The recalled product
- Product
- VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of
- Manufacturer
- Ortho-Clinical Diagnostics
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 (2)
- Software Version 3.2 and below
- Serial Numbers J46001001 -J4600636
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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