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vrijdag 27 juli 2018

IGJ waarschuwingen: Bio-Rad_DiaMed FSCA 003-18 - LIH-Com Kit Fullversion and IH-Com Kit For Reader

Bio-Rad_DiaMed FSCA 003-18 - LIH-Com Kit Fullversion and IH-Com Kit For Reader
Further to a customer complaint, we have confirmed a software anomaly in IH-Com version 5.1. This anomaly only affects the QC module for ABO forward grouping of IH-Com.
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B.Braun INC LP 267_18 & 286_18 - Safil en Novosyn
Uit een interne non-conformitieit heeft de fabrikant vastgesteld dat van sommige eenheden van de genoemde charges de verpakking beschadigd is, waardoor de steriliteit van het product is aangetast.
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CerTest Biotec 183000022 FSCA - VIASURE Flu A, Flu B and RSV Real Time PCR Detection Kit
Lot ABR224-004 of VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit to be used on BD MAX™ showed some slight amplification signals tor Flu B channel that can be interpreted as positive and it led to false positive results tor Influenza B virus.The identified cause was that a batch enzyme with initial low activity was used for manufacturing ABR224-004 lot affected.
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Thermo Fisher_Remel R30164001 - Shigella boydii Polyvalent 2 (7 to 11)
An internal technical investigation has determined that Thermo Scientific™ Remel™ Shigella boydii Polyvalent 2 (7 to 11) R30164001 (lots listed above) may fail to agglutinate within the specified minimum reaction time when tested with serogroup 7 bacteria.
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FREI AG Aktive Reha-Systeme -FSCA 18-2017 - FREI AG portable and height adjustable training table
The products have 2 casters on one side and 2 height adjusters on the other side. The height adjusters have to be countered, otherwise they can come unscrewed, fall off or collapse. Unsecured height adjusters can lead to considerable injuries.
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