Ortho VITROS 4600 Chemistry System Recalled for Software Error
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may associate incorrect patient demographics with sample IDs.
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 and involves a risk of harm (incorrect patient data association) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 4600 Chemistry System due to an identified anomaly in VITROS System Software Version 3.0 and below. The recall affects 81 domestic units and 238 foreign units distributed worldwide, including the United States, Puerto Rico, and various international locations.
Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number. This error could lead to the misattribution of patient information to test results.
Healthcare facilities and users of the VITROS 4600 Chemistry System should contact Ortho-Clinical Diagnostics for instructions on how to address the software anomaly. The recall is classified as Class II by the FDA.
The recalled product
- Product
- VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, r
- 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)
- Serial Numbers J46000108 - J46000440 (J Numbers are analogous to Serial Numbers
- for VITROS 4600 systems the J Numbers start with 4600XXXX)
Distribution
Part of a larger recall action
This product is one of 3 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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