VITROS XT 3400 Chemistry System with Version 3.7.2 and recall
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Why was VITROS XT 3400 Chemistry System with Version 3.7.2 and recalled?
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
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?
UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer
- Product
- VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 506 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)