enGen (TM) Laboratory Automation System Configured with recall: Software Issue
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes…
Why was enGen (TM) Laboratory Automation System Configured with recalled?
Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.
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 (TM) Laboratory Automation Systems configured with TCAutomation" Software version 3.5
- Product
- enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- Domestic: 6 units, Foreign: 3 units
- Distribution
- Worldwide Distribution - US including the states of Arizona, Delaware, Ohio, Tennessee, and North Carolina; and the countries of Mexico, England and Italy.
- Recall date
- June 18, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)