Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly where user-modified parameters revert to default values during ADD installation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text describes a software configuration error without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary measures where harm has not been reported.
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 Catalog Number/Product Code 6801375 (UDI 10758750001132) and Catalog Number/Product Code 6801890 (UDI 10758750001644). These devices are intended for the in vitro quantitative measurement of a variety of analytes of clinical interest.
The recall is due to a software anomaly occurring during ADD installation on systems using Software Versions 2.2.1 through 2.8. The issue causes user-modified parameters to not be saved as expected; instead, the parameters remain changed to the default values obtained from the ADD disk.
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. The recall includes specific serial numbers for both catalog numbers, ranging from 34000119 through 34002323 for Catalog # 6801375 and a specific list of J-prefixed serial numbers for Catalog # 6801890.
Users of these devices should contact Ortho-Clinical Diagnostics for instructions on how to address the software anomaly. The source text does not specify a particular consumer action beyond the recall notification, but standard procedure involves verifying device serial numbers against the provided list and contacting the manufacturer for remediation.
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. Intended for use in the in vitro…
- 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 (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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