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 unexpected assay calibration when using specific calibrator barcode labels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential software anomaly without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics (OCD) is recalling VITROS 4600 Chemistry Systems and VITROS Integrated Systems. The recall affects units running Software Version 3.0 and below with serial numbers J46000012 through J46000456. The affected systems are intended for in vitro quantitative measurement of clinical analytes.
OCD identified an anomaly in the software that may cause an unexpected assay calibration. This issue occurs when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, specifically if assay targets are unassigned or hidden. Internal testing confirmed this potential for miscalibration.
The recall covers 97 units in the United States and 232 units in foreign countries. Distribution was worldwide, including the US (nationwide and Puerto Rico) and countries such as Australia, Brazil, Canada, and Germany. Users should contact Ortho-Clinical Diagnostics for instructions on how to address the software anomaly.
The recalled product
- Product
- VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. 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 Sli
- 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 (3)
- Software Version 3.0 and below
- Serial Numbers J46000012 - J46000456 (serial numbers are sequential
- J Numbers are analogous to serial numbers)
Distribution
Part of a larger recall action
This product is one of 2 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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