Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.325 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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bioMérieux SA, FSCA#5333, VIDAS Immuno-Assays
Since July 2021, bioMérieux has been receiving an increasing number of complaints linked to a VIDAS® “substrate error”.
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Thermo Fisher Scientific, FSN-2021-010, Pathodxtra Strep Group D Latex
An internal technical investigation has determined that DR0704G Pathodxtra Strep Group D Latex Lots. 3312966 and 3312967 may fail ...
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Abbott Laboratories, FA29SEP2021_LM IRV, ARCH c8000, c16000, i2000SR, i1000SR
Abbott has identified three potential performance issues for the ARCHITECT Software version 9.41 and earlier.
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Medtronic Inc., FSN-FA1207, EndurantTM II/IIs Stent Graft System
Medtronic voert een vrijwillige recall uit van een specifieke subset van ongebruikte 18 Fr Endurant™ en Endurant™ II/IIs ...
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Beckman Coulter, Inc., FA-000604, Access hsTnI Reagent (High Sensitivity Troponin I)
In deze brief vindt u het laatste nieuws over mogelijke kruisbesmetting tussen analyses bij de Access hsTnI-test (hooggevoelige ...
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Cook Incorporated, 2021FA0010, Flexor Check-Flo Introducer
Cook Medical heeft vastgesteld dat de introducersheaths van partij 13861362 mogelijk niet correct zijn vervaardigd
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Abbott Laboratories, FA29SEP2021_LM AP, ARCHITECT c4000 & ARCHITECT i2000
Abbott has identified three potential performance issues for the ARCHITECT Software version 9.41 and earlier.
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Radiometer Medical ApS, FSN-2021-10-07, D513 Disposable Waste Container
Radiometer has become aware of a potential issue with the D513 Disposable waste container for the ABL800 analyzers (details ...
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Leica Biosystems Newcastle Ltd, FSN-2021-10-18, BOND™ Ready-to-Use Primary Antibody CDX2 (EP25)
Leico Biosystems recently became aware that the effected device mentioned above may not perform as specified in the IFU. We have ...
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Response Biomedical Corp., FSN-REC05102021, RAMP Troponin I
RAMP® Troponin I Lot# M07797 will not provide test results as the lot card does not match the lot number on the cartridge barcode ...