Recall Z-2184-2018— Cellavision AB
Class II · Ongoing
Class II FDA medical device recall by Cellavision AB, initiated 2017-12-04. It names 2 FDA 510(k) clearances: K092868, K033840. 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 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: 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..
- Recalling firm
- Cellavision AB
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-12-04
- Firm location
- Lund, N/A, Sweden
510(k) clearances named in this recall
2 on FDA's record- K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
- K033840 — CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.