Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2544-2015·Announced 2015-09-09

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.

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 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…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: software-defect

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Ortho-Clinical Diagnostics

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