Agency classClass IIOur severity:High FDA (Devices)·Z-1348-2016·Announced 2016-04-13

Ortho-Clinical VITROS 5600 Integrated System Recalled for Wiring Error

Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a wiring error may leave a module energized when the power cord is unplugged.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (electrical shock hazard) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System, a device intended for the in vitro measurement of a variety of analytes of clinical interest. The recall involves 2,101 total units, with 1,043 distributed domestically in the United States (including Puerto Rico) and 1,058 distributed internationally in countries including Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.

The recall was initiated due to a manufacturing defect where two sets of wires exiting from the EMI filters were switched. This error creates a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged. The affected product codes are 6802413 and 6802915 (Refurbished), with serial numbers ranging from J56000024 to J56002387.

The source text does not specify the actions consumers or healthcare facilities should take in response to this recall.

The recalled product

Product: VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: electrical-shock

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)

Product Codes: 6802413
6802915 (Refurbished) Serial numbers: J56000024 - J56002387

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Ortho-Clinical Diagnostics

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