BD COR System Software recall: Labeling Error
BD COR System Software. Model Number: 444829.
Why was BD COR System Software recalled?
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative 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?
Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
- Product
- BD COR System Software. Model Number: 444829.
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 7 systems
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
- Recall date
- July 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)