Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1290-2019·Announced 2019-05-15

Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunoassay Systems Due to Luminometer Malfunction

Ortho-Clinical Diagnostics is recalling 28 VITROS 3600 Immunoassay Systems because a luminometer malfunction 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a functional failure (inability to process assays) rather than a direct physical injury or death, fitting the Moderate severity criteria for a device malfunction without reported harm.

Plain-English summary

Ortho-Clinical Diagnostics is recalling 28 units of the VITROS 3600 Immunoassay System, specifically refurbished units with software version 3.3.2 or below. The recall is due to a luminometer malfunction that may cause the system to be unable to process MicroWell assays.

The affected systems are those that had the luminometer replaced during a service repair. The recall covers units distributed worldwide, including the United States and 23 other countries. The product is used for the in vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.

Healthcare facilities and users should stop using the affected systems and contact Ortho-Clinical Diagnostics for further instructions on how to resolve the issue.

The recalled product

Product: VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 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 — In Vitro Diagnostics
Hazard: malfunction
inability-to-process
Affected units: 28

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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Same hazard · malfunction