Recall Z-1651-2013— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-05-06, terminated 2018-05-16. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-06
- Terminated
- 2018-05-16
- Firm location
- Rochester, NY, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.