enGen Laboratory Automation Systems recall: Software Issue
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest…
Why was enGen Laboratory Automation Systems recalled?
Software anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6 , v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems.
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?
TCA Software versions 2.6 , 3.2 and 3.5 configured with Bypass Modules for ADVIA Centaur (R), Abbott Architect (TM), VITROS (R) and/or Tosoh AIA (R) Systems
- Product
- enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- Domestic - 31 units; Foreign - 77 units
- Distribution
- Worldwide Distribution: US Nationwide including Puerto Rico, and countries of: Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
- Recall date
- June 18, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)