VITROS XT 7600 Integrated System recall: Software Issue
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in…
Why was VITROS XT 7600 Integrated System recalled?
One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
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?
Systems Running Software Version 3.4 & 3.4.1
- Product
- VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 80
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA. The products were distributed to the following foreign countries: Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom
- Recall date
- May 1, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)