Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the Recalled by Cellavision AB Due to A software malfunction was found where WBC, RBC...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cellavision AB directly.
Affected Products
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
Quantity: Instruments: 224 Software: 99 (US)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cellavision AB
Cellavision AB has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report