Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Biokit SV 19_01 - QUANTIA RF
Biokit has confirmed calibration failures with the indicated product and lot. Upon trying to calibrate the lot 01518H000, the ...
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STANDARD DIAGNOSTICS, FA18001, SD BIOLINE Chikungunya IgM
Standard Diagnostic, Inc. heeft een klacht ontvangen dat de gevoeligheid van de SD BIOLINE chikungunyatest lager is dan ...
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Roche Diagnostics, CN-412018, BILD2 (Bilirubin direct Gen.2)
A low control recovery of BILD2 was observed immediately after cassette opening, with subsequent calibration of the affected ...
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Abbott, FA29MAR2019, Alinity hq Analyzer
There is a potential for delay in the generation of patient results due to the increase in step loss on axis errors and seizing ...
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bioMérieux 4215 FSCA - VITEK® 2 ID_AST Card Types
A potential issue was identified related to the top seal of card pouches containing the VITEK® 2 test cards for the product lots ...
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BÜHLMANN Laboratories AG, 2019.01, IBDoc Portal
Een fout in het uploaden van de testresultaten naar de IBDoc® Portal voor uw patiënt(en) is [n] keer voorgekomen
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Thermo Fisher CM1106B.2465237 - Oxoid CM1106B Brilliance UTI Clarity Agar
An internal technical investigation by Oxoid Limited, part of Thermo Fisher Scientific, has confirmed that Escherichia coli may ...
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Roche Diagnostics GmbH - CN-438868 - cobas p507 post-analytical unit
The Tray Input Flap on the cobas p 501 and cobas p 701 post-analytical units has the potential to become unsecured from the ...
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BioFire FSCA 4280-1 - FilmArray® Gastrointestinal (GI) Panel
The purpose of this letter is to inform you that BioFire Diagnostics, LLC (BioFire) has identified an increased risk of false ...
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Beckman Coulter, FA-19008, DxA 5000
We have received and observed several instances in which, due to a software anomaly, samples remain waiting on the DxA system and ...