Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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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 ...
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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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SSI Diagnostica A/S, Inc., Complaint no. 120-2021, ImmuView S. pneumoniae and L. pneumophila
Due to a production error, the positive control is not correct.
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Beckman Coulter, Inc., FA-21046, Power Processor
Naar aanleiding van interne onderzoeken hebben we ontdekt dat de spatbescherming die op de track aanwezig hoort te zijn, niet in ...
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Abbott Molecular, FA-AM-SEP2021-260, Alinity m SARS-CoV-2 AMP Kit ...
This letter contains important information regarding potential false positive results when using Alinity m SARS-CoV-2 AMP Kit ...
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Roche Diagnostics, CN-588981 (SBN-RDS-Molecular Lab-2021-011), cobas EGFR Mutation Test v2
Roche received complaints reporting the generation of false Mutation Detected results for the exon20 insertion (Ex20Ins) mutation ...
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Roche Diagnostics CN-603821 (SBN-RDS-POC-2021-010) - cobas SARS-CoV-2 & Influenza A/B Test
Roche has received an increased number of complaints from customers when using cobas® SARS-CoV-2 & Influenza A/B Test for use on ...