PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 20, 2018 Initiated: December 4, 2017 #Z-2184-2018

Product 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

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.

Details

Recalling Firm
Cellavision AB
Units Affected
Instruments: 224 Software: 99 (US)
Distribution
US Nationwide in the states of FL, IL, NY, and NC
Location
Lund, N/A

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Cellavision AB. Units affected: Instruments: 224 Software: 99 (US).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2184-2018.

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