Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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IMMUNOTECH SAS, FSN-FA-000664, Stem-Kit Reagents 50 Tests
Beckman Coulter heeft ontdekt dat de aanbevolen bewaartemperatuur van het specimen en de stabiliteit van het bereide sample voor ...
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Siemens Healthcare Diagnostics IMC 21-05 - IMMULITE Systems AlaTOP Allergy Screen Assay
Siemens Healthcare Diagnostics has confirmed through internal investigation that the IMMULITE®/IMMULITE® 1000 assay and IMMULITE® ...
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Agilent Technologies Singapore Pte Ltd. FSN-EnVision FLEX Hematoxylin Link K8008 EnVision FLEX Hematoxylin Link
Some customers have reported weak counterstaining with the EnVision FLEX Hematoxylin (Link) Kit lot number 41246596 with Vial lot ...
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Abbott Diagnostics FA12JUL2021 - Alinity s System
Abbott has identified an issue with liquid waste pressure monitoring. This communication provides actions to be followed until ...
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bioMérieux SA, FSN-FSCA 5230, ETEST®IMIPENEM RELEBACTAM-WW & US
This letter is intended for all ETEST® Imipenem/Relebactam (IPR) (Ref: 420925 & 420927) users.
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Leica Biosystems Melbourne Pty. Ltd., FSN-202106-01, BOND-MAX, BOND-III
This is to notify you that the BOND ID Imager in your instrument provided by Leica Biosystems Melbourne has been observed to ...
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BioFire Diagnostics, LLC, FSN-FSCA 5183, PN plus Panel
The purpose of this letter is to inform you that BioFire Diagnostics, LLC has identified a potential for elevated rates of false ...
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Siemens Healthcare Diagnostics Inc., FSN-ASI 21-03, Atellica CH 930 Analyzer
The purpose of this communication is to inform you of an issue with the product Atellica CH 930 Analyzer.
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Roche Diagnostics GmbH, FSN-CN-593343 (SBN-RDS-CoreLab-2021-006), cobas® 6500 urine analyzer series (cobas u 701 microscopy analyzer in combination with cobas u 601 urine analyzer)
Urgent Field Safety Notice cobas® 6500: possible sample mismatch software.
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bioMérieux SA, FSN-FSCA 5172, Sabouraud 2 agar (SAB2-T)
During internal tes ting, a growth defect was observed for Candida on the product Sabouraud 2 agar tubes (SAB2 T).