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 devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
Class I - DangerousWhat Should You Do?
- Check if you have this product: Versions 6.0.1 or 6.0.2
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cellavision AB
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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 devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
Product Codes/Lot Numbers:
Versions 6.0.1 or 6.0.2
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2184-2018
Related Recalls
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.