Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1291-2019·Announced 2019-05-15

Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Luminometer Malfunction

Ortho-Clinical Diagnostics is recalling 62 VITROS XT 7600 Integrated Systems worldwide 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, and the source text does not report any injuries, illnesses, or deaths, indicating a risk that is unlikely to cause serious adverse health consequences.

Plain-English summary

Ortho-Clinical Diagnostics is recalling 62 units of the VITROS XT 7600 Integrated System, software version 3.4.1 and below. The recall affects systems with serial numbers 76000108 and above, identified by UDI 1075870031610. These devices are used for in vitro quantitative, semi-quantitative, and qualitative measurement of 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 VITROS systems. This defect may impact the ability to perform specific diagnostic tests on the affected equipment.

The affected units were distributed worldwide, including the United States (nationwide) 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 of these systems should contact Ortho-Clinical Diagnostics for further instructions on how to address the malfunction.

The recalled product

Product: VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 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 Diagnostic Equipment
Hazard: equipment-malfunction
inability-to-process-assays
Affected units: 62

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 (1)

Serial Numbers: 76000108 & above UDI: 1075870031610

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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