Moderate FDA (Devices)·Z-0231-2016·Announced 2015-11-11

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.

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 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 qu
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: software-error
mis-labeling

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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