Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Illumina, QI-00398, VeriSeq™ NIPT Solution v2
Illumina has received reports of samples in column 11 having low Non-Excluded Sites (NES) resulting in iFACT failures leading to ...
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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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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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bioMérieux SA FSCA 5202-1 - VIDAS Anti-HBs Total II
Based on complaints received with results identified as discordant and potential false positive by some customers, bioMérieux ...
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Siemens Healthcare Diagnostics Inc., FSN-CC 21-06, ADVIA Centaur Syphilis
The purpose of this communication is to inform you of an issue with the product ADVIA Centaur Syphilis.
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Roche Diagnostics GmbH, FSN-CN-358714 (SBN-RDS-CPS-2021-003), IRON 2
Urgent Field Safety Notice Iron Gen.2: throughput dependent signal drifts on cobas c 311, cobas c 501/502 and COBAS INTEGRA® 400 ...
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Roche Molecular Systems, FSN-CN-560213,-563436,-566153(SBN-RMD-2021-005), cobas® SARS-CoV-2 & Influenza A/B Test
Urgent Field Safety Notice cobas® SARS-CoV-2 & Influenza A/B – Invalids and False Positive results.
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Microbiologics, Inc.,FSN-Recall 2020-003_0947, KWIK-STIK™ 0947P-K-LYFO-DISK_QC Sets&Panels 5193P
Dringend bericht inzake de unassayed kwaliteitscontrolemateriaal voor microbiologische assays.
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ABBOTT POINT OF CARE, FSN-APOC2020-007, i-STAT CG8+ and EG7+ Cartridges
This letter contains important information regarding the i-STAT® CG8+ and EG7+ cartridges.
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Siemens Healthcare Diagnostics ASW 21-02 - Atellica IM 1300_1600 and CH 930 Analyzer
Siemens Healthcare Diagnostics has identified the following issues with the Atellica Solution products listed in Table 1, which ...