Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1735-2014·Announced 2014-06-18

Ortho-Clinical VITROS 5600 Integrated System Recalled for Biased Results

Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software issue that may cause biased results when using Multiple Window codes.

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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System, Product Code/Catalog Number 6802413, for in vitro diagnostic use. The recall affects units with Software Version 3.0 and lower, specifically serial numbers J56000110 through J56001912. The company has recalled 835 units for domestic distribution and 921 units for foreign distribution.

The recall is issued because of a potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System, and the VITROS 5,1 Chemistry System. MW codes may be associated with results from these products using multiple point (multipoint) rate measurements, which could affect MicroSlide assays.

The affected products were distributed worldwide, including in the United States, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Users of these systems should contact Ortho-Clinical Diagnostics for further instructions on how to address the software issue.

The recalled product

Product: VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostic
Hazard: 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 (2)

Software Version 3.0 and lower
Serial Numbers J56000110 through J56001912

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 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.

See all 3 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · mis labeling