ORTHO¿ Assay Software — Class II medical device recall Z-1651-2013

Terminated recall by Ortho-Clinical Diagnostics, reported 2013-07-10, distributed nationwide. There is evidence that an electrical short within the systems connector has caused an accumulation of heat whi

Recall number	`Z-1651-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Ortho-Clinical Diagnostics, Rochester, NY, United States
Recall initiated	2013-05-06
Classified	2013-07-01
Reported by FDA	2013-07-10
Terminated	2018-05-16
Distributed	Nationwide (US)
Countries outside the US	AU, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE
Quantity	31 units
Serial numbers	`0811F06216`
Model numbers	`6842840`

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 pipetting protocols and ORTHO Assay Software (OAS), OSS automates many of the processing functions and data management requirements associated with ELISA (enzyme-linked immunosorbent assay) microplate testing.

Reason for recall

There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1651-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.