The Recall Desk
SevereFDA (Devices)·Z-1651-2013·Announced 2013-07-10

Ortho Assay Software Server Recalled Due to Electrical Short and Heat

Ortho-Clinical Diagnostics is recalling 31 units of the ORTHO Assay Software Server because an electrical short caused heat accumulation and melted wiring.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect (electrical short) that resulted in physical damage (melted wires and connectors) and heat accumulation, which aligns with the rubric criteria for significant injury or property damage reports.

Plain-English summary

Ortho-Clinical Diagnostics is recalling 31 units of the ORTHO Assay Software (OAS) Server, Catalog # 6842840. This software server is part of the ORTHO Summit System, a modular, integrated system used for licensed blood screening tests and ELISA microplate testing.

The recall was initiated because there is evidence that an electrical short within the system's connector caused an accumulation of heat. This heat radiated back through the wiring harness, causing the wires and connectors to melt.

The affected units were distributed worldwide, including nationwide in the United States and in various international countries. The specific serial numbers involved range from 0811F06216 through 0811F06225, 0911F06240 through 0911F06245, and 1011F06317 through 1011F06331. Users should contact the manufacturer for further instructions regarding the recall.

The recalled product

Product
ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network, assay-specific
Manufacturer
Ortho-Clinical Diagnostics
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
31

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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