The Recall Desk
SevereFDA (Devices)·Z-1648-2013·Announced 2013-07-10

Ortho-Clinical VITROS 4600 Chemistry System Recalled for Electrical Short

Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because an electrical short in the connector 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/electrical defect in a medical device that caused physical damage (melting of wires and connectors) due to heat accumulation, which fits the criteria for a Severe recall involving significant injury or property damage risks.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 4600 Chemistry System (product code 6802445) due to a safety hazard involving the system's electrical components. The recall affects a total of 69 units, with 28 units distributed domestically in the United States and 41 units distributed internationally.

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 serial numbers are J46000021 and J46000110 through J46000177.

The product is used for in vitro quantitative measurement of various clinical analytes. Users should check their equipment serial numbers against the affected range and contact the manufacturer for further instructions.

The recalled product

Product
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, io
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: J46000021
  • J46000110 through J46000177

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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