Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1288-2019·Announced 2019-05-15

Ortho-Clinical VITROS 5600 Systems Recalled for Luminometer Malfunction

Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a luminometer malfunction that may prevent the processing of MicroWell assays.

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 hospitalizations are reported in the source text.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems, specifically refurbished units with software version 3.3.2 or below. The recall affects four units that had their luminometer replaced during a service repair. The product is used for in vitro quantitative, semi-quantitative, and qualitative measurement of various clinical analytes using VITROS Immunodiagnostic Products Reagents.

The recall is being issued because a luminometer malfunction may cause an inability to process MicroWell assays on the affected systems. This defect could impact the ability of laboratories to perform specific tests on the affected equipment.

The affected units were distributed worldwide, including the United States and countries such as Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the recall.

The recalled product

Product: VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — Laboratory Equipment
Hazard: malfunction
inability-to-process
Affected units: 4

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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