Reported Jun 20, 2018 · Ongoing
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600…
Cellavision AB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cellavision AB · Forskningsbyn Ideon · Lund, N/A · N/A
Is this the product you have?
- CellaVision DM Software versions 6.0.1 or 6.0.2
- installed on the following products
CellaVision DM96DM1200
- DM9600 and DI-60 Product UsageThe 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
- Lot codes and dates
- Versions 6.0.1 or 6.0.2
- Amount recalled
- Instruments: 224 Software: 99 (US)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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