enGen Laboratory Automation System recall: Software Issue
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative…
Why was enGen Laboratory Automation System recalled?
A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
enGen Laboratory Automation Systems and VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Scientific Aliquoter & Labeller Module and using Software Versions 4.6 and below
- Product
- enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative…
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 40 units
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom.
- Recall date
- January 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)