VITROS XT7600 Integrated System recall
VITROS XT7600 Integrated System
Why was VITROS XT7600 Integrated System recalled?
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive).
- Product
- VITROS XT7600 Integrated System
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 1,720 units (834 US, 886 OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
- Recall date
- March 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)