Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry System Software
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may incorrectly extend reagent stability time.
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 software anomaly without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 1,105 units of the VITROS 5,1 FS Chemistry System, Version 3.0 and below. The recall is due to a software anomaly that may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
The affected devices are used for the in vitro quantitative measurement of various analytes in biological fluids such as serum, plasma, urine, and cerebrospinal fluid. The recall covers units distributed nationwide in the United States. The specific product code is 6801375, with UDI 10758750001132 and serial numbers ranging from J34000132 to J34002322.
Healthcare facilities and users should check their inventory for these specific serial numbers and contact Ortho-Clinical Diagnostics for instructions on how to proceed with the recall.
The recalled product
- Product
- VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 1,105
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 (1)
- Product code: 6801375 UDI: 10758750001132 Serial Numbers: J34000132- J34002322
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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