Agency classClass IIOur severity:High FDA (Devices)·Z-0801-2021·Announced 2021-01-13

Ortho-Clinical VITROS Automation Software Recall for Sample Labeling Errors

Ortho-Clinical Diagnostics is recalling VITROS Automation Solutions software due to a defect that may cause samples to be mislabeled, potentially leading to incorrect 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: The recall is classified as FDA Class II and involves a risk of patient injury due to mislabeled samples, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling 40 units of VITROS Automation Solutions (VAS), Catalog Numbers 6844300 and 6844301. These devices are intended to automate pre-analytical and post-analytical sample processing in clinical laboratories. The recall involves systems using enGen Laboratory Automation Systems and VITROS Automation Solutions configured with Thermo Scientific Aliquoter & Labeller Module and using Software Versions 4.6 and below.

The recall was initiated because a software anomaly may cause an aliquoted sample to be labeled as the incorrect sample. This error may lead to laboratory results being associated with the wrong patient sample, which could result in inappropriate medical intervention and potential injury to the patient.

The affected units were distributed worldwide, including nationwide distribution in the United States (specifically CA, CO, MA, MD, NC, OH, TX, VA, and VT) and in Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and the United Kingdom. Clinical laboratories should contact Ortho-Clinical Diagnostics for instructions on how to address the software anomaly.

The recalled product

Product: VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
Manufacturer: Ortho-Clinical Diagnostics, Inc.
Category: Medical Device — Laboratory Automation
Hazard: mis-labeling
patient-injury
Affected units: 40

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics, Inc.

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Same hazard · mis labeling