Agency classClass IIOur severity:High FDA (Devices)·Z-1225-2024·Announced 2024-03-13

Laboratory analyzer software defect may cause erroneous patient test results

A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.

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: This is a Class II medical device recall involving laboratory test equipment. The software defect creates potential for patient harm through erroneous test results that could affect clinical decision-making. However, no illnesses or injuries have been reported, fitting the 'risk-of-harm products where injury has not yet been reported' category.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling certain VITROS 4600 Chemistry Systems (Catalog Nos. 6802445 regular and 6900440 refurbished) running software version 3.8.1 due to a software defect that prevents quality control (QC) baseline statistics from updating as expected when changed by the user.

This defect may cause erroneous patient results to be reported from affected devices. Quality control baseline statistics are critical for ensuring the accuracy of laboratory test results, and failure to update them properly could lead to incorrect patient data being reported.

Four affected devices have been identified in the United States, distributed across 21 states including Arizona, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, Wisconsin, and West Virginia. An additional 18 devices have been distributed internationally to Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, the United Kingdom, Italy, Spain, Russia, France, and Belgium.

The recalled product

Product: VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Manufacturer: Ortho-Clinical Diagnostics, Inc.
Category: Medical Device — Clinical Laboratory Equipment
Hazard: software-defect
erroneous-results

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Ortho-Clinical Diagnostics, Inc. 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 →

Same manufacturer · Ortho-Clinical Diagnostics, Inc.

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Same hazard · software defect