Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
569 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Siemens Healthcare Diagnostics Inc, ACHC 23-03, Atellica CH Toxicology Calibrator
Siemens Healthcare Diagnostics Inc. received customer complaints regarding a positive bias for the Atellica CH Salicylate (Sal) ...
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Phadia AB, QA2023-05, EliA GBM Well
Several customer complaints have been reported where specific samples produced false positive EliA GBM results. An investigation ...
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SENTINEL CH. S.p.A., 01.2023, CALiaGold Calibrator Control Set Sample Diluent
Based on the data collected from some customer sites, a high recovery of CALiaGold Control Set IREFj 1151200 may be found.
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RAL Diagnostics, NC 23.042, Buffer solutions for automated systems
De gebruiker heeft bacteriën gevonden in bloeduitstrijkjes en er werden intern klachten van klanten gemeld.
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ROCAMED France,FSCA-03-2023-1,Urology suction tubing with pump body
ROCAMED SAM has received complaints about Urology Suction Tubing with Pump Body of reference SOUR9200ST12 of lot R006497. The ...
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MED TRUST Handelsges.m.b.H., FSN-2023-01, Wellion LUNA TEST STRIPS 10 GLU
Re·call Wellion LUNA duo/trio meter sets and teststrips. During an unannounced audit by TUV Rheinland it was detected that the ...
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Illumina Inc, QI-01093, NextSeq 550Dx Instrument . MiSeq Dx Instrument
Illumina neemt contact met u op vanwege een cybersecurityprobleem in de software van de Universal Copy Service (UCS) dat is ...
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Waters Corporation, 1218959-11.17.2021-003-C, Waters 3777C Sample Manager IVD
After investigation, a defect has been found that can result in a single sample being injected and recorded against the incorrect ...
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Beckman Coulter Inc., 23011, iQ200 Series DxU 850m and 840m Iris Analyzers
Beckman Coulter heeft kennis genomen van een intermitterend probleem waarbij de optionele markering “Previous Sample Had Sperm” ...
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Beckman Coulter Ireland Inc., 000884, Bicarbonate
Beckman Coulter has confirmed a premature decrease in calibratior ODs for the following lots of Bicarbonate OSR6x90.