Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Hamilton Bonaduz AG, FSCA-2023-01, CO-RE Tips CO-RE II Tips
As root cause the filter has been identified. Said filter is being inserted into to the tip during production.
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Beckman Coulter, Inc., FSN-FA 23021, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter heeft vastgesteld dat de hierboven vermelde softwareversie van de DxI 9000 Access-immunoassay-analyser het aantal ...
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Abbott Diagnostics Technologies AS, FSN-CAPA-00005233, Alere Afinion 2 Afinion 2
Abbott has identified an issue related to overheating of Afinion 2 instruments with software version ≤ 21.13.
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EUREKA SRL LAB DIVISION, FSN-01/2023, Noradrenalina IVD, calibrator and control
A thorough examination at customer site of the calibrator performance showed that the Noradrenaline values were overestimated. ...
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QIAGEN GmbH, FSN-CI 3028397, QIAstat-Dx® Respiratory SARS-CoV-2 Panel
Deze dringende veiligheidsmededeling dient om u erover te informeren dat QIAGEN heeft vastgesteld dat bepaalde partijen van de ...
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Siemens Healthcare Diagnostics Inc, ACHC 23-03, Atellica CH Toxicology Calibrator
Siemens Healthcare Diagnostics Inc. received customer complaints regarding a positive bias for the Atellica CH Salicylate (Sal) ...
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Phadia AB, QA2023-05, EliA GBM Well
Several customer complaints have been reported where specific samples produced false positive EliA GBM results. An investigation ...
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SENTINEL CH. S.p.A., 01.2023, CALiaGold Calibrator Control Set Sample Diluent
Based on the data collected from some customer sites, a high recovery of CALiaGold Control Set IREFj 1151200 may be found.
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RAL Diagnostics, NC 23.042, Buffer solutions for automated systems
De gebruiker heeft bacteriën gevonden in bloeduitstrijkjes en er werden intern klachten van klanten gemeld.
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ROCAMED France,FSCA-03-2023-1,Urology suction tubing with pump body
ROCAMED SAM has received complaints about Urology Suction Tubing with Pump Body of reference SOUR9200ST12 of lot R006497. The ...