Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Beckman Coulter, 23001, Access 2 Immunoassay-analyser, Access 2-gedeelte, DxC 600i
Beckman Coulter heeft vastgesteld dat de draadschroefmoerband van de wasarm van de Access-2 breukgevoelig is.
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DiaMed, FSCA 001-23, IH-1000
When one or multiple Crossmatch tests and Auto control tests are requested in IH-Com, under certain circumstances described ...
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Siemens Healthcare Diagnostics Inc, DC 23-03, Dimension Tacrolimus Flex Reagent Cartridge
Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with ...
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BioMérieux SA, FSN-FSCA 5742-1, MUELLER HINTON E AGAR
Following customer complaints, a performance limitation with the combination Pseudomonas aeruginosa - Gentamicin on MUELLER ...
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One Lambda Inc, PN# 2022-0593;MDSS ref.:IVD22.022, LinkSēq™ HLA-ABCDRDQDP+ 384 Typing Kit
There is a risk of incorrect test results assigned to patient sample. Transplants require confirmatory testing derived from ...
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GENERI BIOTECH s.r.o., FSCA_UGT1A1_02_2022, gb PHARM UGT1A1
An incorrectly determined genotype may affect the confirmation or exclusion of Gilbert syndrome. Based on the genotype ...
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EPOCAL Inc., POC 23-004, Epoc Host 2 and Epoc NXS Host
Siemens Healthcare Diagnostics Inc. has confirmed an issue through complaint investigation. The issue has the potential to affect ...
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Siemens Healthcare Diagnostics Inc, IMC 23-04, IMMULITE® 2000 Thryoglobulin
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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GENERI BIOTECH s.r.o, FSCA_UGT1A1_01_2022, gb PHARM UGT1A1
The list of PCR cyclers in the User Manual contains incorrect information about the possibility of using the Rotor-Gene PCR ...
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Ortho Clinical Diagnostics Inc, CL2022-298, ORTHO VISION and VISION Max Analyzers for BioVue
The purpose of this notification is to inform you of a potential for false positive results during a probe replacement process ...