Agency classClass IIOur severity:High FDA (Devices)·Z-1734-2014·Announced 2014-06-18

Ortho-Clinical VITROS 4600 Chemistry System Recalled for Biased Results

Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems due to a potential for biased results when using Multiple Window codes.

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 medical device with a potential for biased diagnostic results, which poses a risk of harm to patients through incorrect clinical decisions, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445, for in vitro diagnostic use. The recall affects units with Software Version 3.0 and lower and serial numbers J46000108 through J46000403. The total quantity involved is 82 domestic units and 213 foreign units.

The recall is issued because of a potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System, and the VITROS 5,1 Chemistry System. MW codes may be associated with results from VITROS Chemistry Products using multiple point (multipoint) rate measurements.

The affected products were distributed worldwide, including the United States, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Users of these systems should contact Ortho-Clinical Diagnostics for further instructions regarding the recall.

The recalled product

Product: VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostic
Hazard: biased-results

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)

Software Version 3.0 and lower
Serial Numbers J46000108 through J46000403

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · biased results