Ortho-Clinical enGen Laboratory Automation System Software Recall
Ortho-Clinical Diagnostics is recalling 40 enGen Laboratory Automation Systems due to a software anomaly that may cause sample mislabeling, potentially leading to incorrect patient results and inappropriate medical intervention.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of injury to patients due to potential inappropriate medical intervention resulting from sample mislabeling, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling 40 units of the enGen Laboratory Automation System and enGen Track System. The recall involves systems configured with Thermo Scientific Aliquoter & Labeller Module and using Software Versions 4.6 and below. The product is intended for in vitro quantitative measurement of clinical analytes using VITROS Chemistry Products.
The recall is due to a software anomaly that may cause an aliquoted sample to be labeled as the incorrect sample. This error may lead to test results being associated with the wrong patient sample, potentially resulting in inappropriate medical intervention and injury to the patient.
The affected units were distributed worldwide, including in the United States (CA, CO, MA, MD, NC, OH, TX, VA, VT) and in Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and the United Kingdom. Users should contact Ortho-Clinical Diagnostics for further instructions on how to address the software anomaly.
The recalled product
- Product
- enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended 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…
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 40
Distribution
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.
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