CellaVision DM Software versions 6.0.1 or 6.0.2 recall: Software Issue
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The…
Why was CellaVision DM Software versions 6.0.1 or 6.0.2 recalled?
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
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?
Versions 6.0.1 or 6.0.2
- Product
- CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The…
- Recalling firm
- Cellavision AB
- Quantity
- Instruments: 224 Software: 99 (US)
- Distribution
- US Nationwide in the states of FL, IL, NY, and NC
- Recall date
- June 20, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)