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Maquet_Getinge FSCA 598097 - Heater Unit HU 35

Based on the internal complaints investigation and extensive material compatibility testing under aggrevated conditions ...

Waarschuwing | 18-05-2022

Biomedical Data Solutions FSCA 64581 - Ortho Connect

It has been identified that an end user site had attempted to perform QC on a single test using multiple QC kits. The Quality ...

Waarschuwing | 18-05-2022

Siemens Healthcare Diagnostics PH-22-005-A-C - INNOVANCE D-Dimer Controls

The purpose of this communication is to inform you about the potential risk of allergic skin reactions in case of direct skin ...

Waarschuwing | 18-05-2022

Ortho Clinical Diagnostics CL2022-099 - ORTHO VISION and VISION Max Analyzers

Ortho Clinical Diagnostics received complaints in which customers obtained unexpected results on their ORTHO VISION analyzer. ...

Waarschuwing | 18-05-2022

DiaSys Diagnostic Systems NCR 22-46 - HDL-c direct FS

During internal control measurements, a carryover effect of Bilirubin Auto Total FS into HDL-c direct FS was discovered on the ...

Waarschuwing | 18-05-2022

Ortho Clinical Diagnostics CL2022-094 - ORTHO Optix Reader

Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in ...

Waarschuwing | 18-05-2022

MAQUET SAS, FSN-MSA-605552, Volista STANDOP

Under certain conditions, it was established that the paint could chip on a specific part of the fork. Therefore, there is a risk ...

Waarschuwing | 17-05-2022

Siemens Healthcare GmbH, AX026/21/S (FSCA), AX027/21/S (FSN), ARTIS icono

In rare cases an interruption of the protective earth and loss of detection of fault current might occur. If the protective earth ...

Waarschuwing | 17-05-2022

WEINMANN Emergency Medical Technology GmbH + Co. KG, FSCA AVP 2022-03.01, Li-Ion battery for ACCUVAC Pro

Based on customer feedback, we have determined that the ACCUVAC Pro switches off completely after approx. 3s in battery operation ...

Waarschuwing | 17-05-2022

Medi-Globe GmbH, DE-MF-000007998, GUS-42-18-022 EBUS TBNA Ultrasound Needle System

We zijn op de hoogte van een kwalitatief probleem met het bovengenoemde product, zodat onbeperkt, veilige behandeling van de ...

Waarschuwing | 17-05-2022