Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Biohit Oyj, 144-22, BIOHIT ColonView quick test
lf the specified kit lot has been used, a minor possibility for a false negative result still exists. In such a case there would ...
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Leica Biosystems Melbourne Pty Ltd, 202209-01, ThermoBrite Elite
Thermische uitschakeling Er is vastgesteld dat de thermische uitschakelingsschakelaar, een automatisch resettende thermische ...
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Leica Biosystems Newcastle, IR 66/22, NovocastraTM Muscle Specific Actin
Leica Biosystems Newcastle recently became aware the IFU of affected device mentioned above incorrectly states a suggested ...
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Randox Laboratories Ltd., REC629, Randox Specific Protein Control Levels 1-3
Rheumatoid Factor (RF) is a protein whose levels are increased in patients with Rheumatoid Arthritis. Delay in reporting results ...
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Abbott Molecular, FA-AM-NOV2022-283, Alinity m Resp-4-Plex AMP Kit
Abbott has received reports of an increase in reactive negative controls and false positive results, with certain lots of Alinity ...
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Siemens Medical Solutions Diagnostics, AIMC 23-01, Atellica IM Free Prostate-Specific Antigen fPSA
The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide ...
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Abbott Molecular, Inc., FSN-FA-AM-OCT2022-282, Alinity m System
This letter contains important information regarding your Alinity m System; Specifically, the current software installed on your ...
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DiaMed GmbH, FSN-FSCA 003-22, IH-500
We would like to share with you, and your team, information about an issue that could be observed when performing ABO grouping ...
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The Binding Site Group Limited, FSN-AE061, Freelite® Human Lambda Free Kit for use on the Siemens BN ProSpec®
Na een aantal meldingen van klanten en interne tests hebben we vastgesteld dat de kit vermeld in tabel 1 de optische limiet van ...
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Oxoid Deutschland GmbH, FSN-, Columbia CAP Agar with Sheep Blood
A technical investigation has concluded that Proteus spp grew and swarmed on the plate.