Ortho VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may reset user-configured parameters to defaults during installation.
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, but the hazard involves a software configuration reset rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Chemistry System Refurbished. The recall affects units with Software Versions 2.2.1 through 2.8. The specific catalog numbers and unique device identifiers are 6801375 (UDI 10758750001132) and 6801890 (UDI 10758750001644).
The recall is due to a software anomaly that may occur during the installation of an Assay Data Diskette (ADD). If a user is utilizing User-Configured (Modified) parameters, the system may restore all default settings from the ADD instead of retaining the user-modified parameters. This could result in the loss of specific laboratory configurations.
The affected units were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela. Users should contact Ortho-Clinical Diagnostics for instructions on how to address the software issue.
The recalled product
- Product
- VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD --- Ortho Clinical Diagnostics I
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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 (20)
- Software Versions 2.2.1 through 2.8
- Catalog # 6801375 Serial Numbers: 34000119 through 34002323
- Catalog # 6801890 Serial Numbers: J34000133
- J34000193
- J34000197
- J34000212
- J34000285
- J34000316
- J34000318
- J34000337
- J34000360
- J34000420
- J34000451
- J34000478
- J34000495
- J34000497
- J34000529
- J34000538
- J34000552
- J34000557
Distribution
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