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vrijdag 13 juli 2018

IGJ waarschuwingen: Zimmer Biomet, Dermatome AN

Zimmer Biomet, Dermatome AN
The affected devices could potentially have a loose control bar, which could compromise the ability to control the thickness of the graft.
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Roche Diagnostics CN-374866 - cobas p612 pre-analytical system (LCP1)
The current issue deals with the occasional deposition of sample material at the bottom of the sample nozzle and its possible carry over to other specimens.
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Intuitive Surgical ISIFA2018-05-C - Da Vinci Si_Xi_X Surgical System
Deze veiligheidsmededeling is bedoeld om u erover te informeren dat Intuitive Surgical op de hoogte is gebracht dat bepaalde redundante voedingseenheden van medische kwaliteit (RMGPS) in specifieke centrale consoles van da Vinci Si®, Xi® en X® en in operatierobots van da Vinci Si® zijn verzonden met een fabricagefout.
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Cepheid 18FAR006 - Xpert MTB_RIF Ultra assay
Cepheid has received reports that some of our customers have experienced a higher number of probe check (E5007 and E5017) errors than would typically be expected when using this test and its intended use specimen types.
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Roche Diagnostics CN-355457 - (Elecsys) Vitamin D total II
In this update, we would like to inform you that the issue occurs only with plasma samples and we provide you with an updated workaround. Serum samples are not affected and can be measured without workaround. Irrespective of the sample type, we would like to remind you of the importance of pre-analytical handling and sample quality when running Elecsys Vitamin D total II. During the...
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