The Recall Desk
SevereFDA (Devices)·Z-1649-2013·Announced 2013-07-10

Ortho-Clinical VITROS 5600 Integrated System Recalled for Electrical Short

Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to an electrical short that 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 is classified as FDA Class II and involves a structural defect (electrical short) that resulted in physical damage (melted wires and connectors), meeting the criteria for a Severe rating.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System (product code 6802413). The recall involves 381 units, with 227 distributed domestically in the United States and 154 distributed internationally. The affected serial numbers are J56000110, J56000118, and J56001095 through J56001507.

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 agency has classified this as a Class II recall.

The VITROS 5600 Integrated System is used for in vitro quantitative, semi-quantitative, and qualitative measurement of various clinical analytes. Users should contact Ortho-Clinical Diagnostics for instructions on how to proceed with the recall.

The recalled product

Product
VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip
Manufacturer
Ortho-Clinical Diagnostics
Category
Medical Device — Laboratory Equipment
Hazard

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 (2)

  • Serial numbers: J56000110
  • J56000118 and J56001095 through J56001507

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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