https://www.igj.nl/https://www.igj.nl/documenten/fsn-2026/04/10/remel-europe-ltdfsn-2026-002-oxoid-agglutinating-sera.-salmonella-9-0Cross reaction has been identifiedThu, 09 Apr 2026 22:00:00 GMTdoc-69d8b7f361eb45ec9d04ea27https://www.igj.nl/documenten/fsn-2026/04/10/boston-scientific-corporation-97251520d-fa-polarx-and-polarx-fit.polarsheath.smartfreezeBoston Scientific is de prestaties van het systeem blijven monitoren, en in de afgelopen maanden zijn er drie (3) extra gevallen van AE-fistels gemeld, waaronder één (1) dat verband hield met het overlijden van een patiënt.  Thu, 09 Apr 2026 22:00:00 GMTdoc-69d8b343bc0d16f92a0246b2https://www.igj.nl/documenten/fsn-2026/04/09/qiagen-gmbh-dev-05442-qiastat-dx-gastrointestinal-panel-2This notification is to inform you that QIAGEN® has determined that lots of QIAstat-Dx Gastrointestinal Panel 2, REF 691412 and 691413, are showing a low-frequency increase of false positive results for the Vibrio cholerae target.Wed, 08 Apr 2026 22:00:00 GMTdoc-69d78f4b61eb4562fc04e0c2https://www.igj.nl/documenten/fsn-2026/04/08/intersurgical-ltd.-484380-various-bvm-resuscitatorsSome devices have been identified during pre-use checks as missing one of the valves at the rear of the BVM Resuscitator, position as shown below.Tue, 07 Apr 2026 22:00:00 GMTdoc-69d65708bc0d166e9a0191ffhttps://www.igj.nl/documenten/fsn-2026/04/07/siemens-healthcare-diagnostics-inc-achc-26-05-atellica-ch-creatine-kinase-ck_lSiemens Healthineers has confirmed, through investigation of customer complaints, the potential for falsely elevated patient, quality control (QC), and/or calibrator results when using Atellica CH Creatine Kinase (CK_L) lot numbers 252591, 252602...Tue, 07 Apr 2026 11:43:00 GMTdoc-69d4efda61eb45135f040733https://www.igj.nl/documenten/fsn-2026/04/07/diagnostica-stago-rc-25-0050-sta-liatest-ddi-plus-.ivdr-class-cAfter receiving customer complaints, Stago conducted thorough investigations and confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.Mon, 06 Apr 2026 22:00:00 GMTdoc-69d5040561eb450e9404093fhttps://www.igj.nl/documenten/fsn-2026/04/07/intuitive-surgical-inc.-isifa2026-02-r-8mm-sureform-30-gray-reload Sinds 23 februari 2026 zijn er vijf meldingen geweest van ernstige incidenten* met betrekking tot onvolledige nietlijnen met grijze cartridges op bloedvaten, met vijf meldingen van bloedingen en één melding van een sterfgeval.Mon, 06 Apr 2026 22:00:00 GMTdoc-69d5089e61eb45537804095fhttps://www.igj.nl/documenten/fsn-2026/04/07/siemens-healthcare-diagnostics-inc.-aimc-26-01-atellica-im-and-advia-centaur-active-b12Siemens Healthineers has confirmed through the investigation of customer complaints thatthe Atellica IM and ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay kit lots listed above may be impacted by one of the following issues: Patient...Mon, 06 Apr 2026 22:00:00 GMTdoc-69d503b0bc0d1696240182dfhttps://www.igj.nl/documenten/fsn-2026/04/07/nucletron-b.v.-fca-nu-0009-cervical.intrauterine-brachytherapy-systemUit een uitgebreide analyse van de onderliggende oorzaak is gebleken dat de belangrijkste factor die heeft bijgedragen aan het losraken van de punt een onvoldoende aanbrenging van de lijm op harsbasis tussen de punt en de binnen- en...Mon, 06 Apr 2026 22:00:00 GMTdoc-69d50de4bc0d160115018439https://www.igj.nl/documenten/fsn-2026/04/07/masimo-corporation-hhe-1088-hhe-1089b-mdss-ref.-md26.035-radius-vsm-ecg-electrodes-and-blood-pressure-cuffsRadius VSM small-and medium-size blood pressure cuffs containing rough edges.  Prolonged rubbing against the rough edge of a Radius VSM blood pressure cuff may result in localized skin irritation or redness. There is no performance impact of the...Mon, 06 Apr 2026 22:00:00 GMTdoc-69d50b54bc0d1637e9018418https://www.igj.nl/documenten/fsn-2026/04/02/waldemar-link-gmbh-co-kg-r-2026-03-spii-model-lubinus-hip-prosthesis-stemDue to a complaint, it has come to our attention that the device laser markings of one production order of SPII Model Lubinus Hip Stems with the article Ref 127-767/26 show the incorrect Article Ref 127-767/17 and the wrong CCD-Angle 117°.Thu, 02 Apr 2026 18:58:00 GMTdoc-69cebde8bc0d16ad1e01643chttps://www.igj.nl/documenten/fsn-2026/04/02/advanced-bionics-llc-3009762645-03232026-r-00001-m-zn-air-battery-pakOn January 23 2026, while performing IEC 60601-1 compatibility testing between a development-stage device and the M Zn-Air Battey Pak, an external test facility identified a non-conformance in the approved product it noted that the...Thu, 02 Apr 2026 18:11:00 GMTdoc-69ceb45f61eb4501f003ed20https://www.igj.nl/documenten/fsn-2026/04/02/ge-healthcare-fmi-85491-centricity-universal-viewerGE HealthCare heeft een mogelijke kwetsbaarheid op het gebied van  cyberbeveiliging vastgesteld die van invloed is op bepaalde versies van Centricity Universal Viewer, inloggegevens van gebruikers kunnen op het lokale werkstation van de...Thu, 02 Apr 2026 08:18:00 GMTdoc-69ce268661eb45146603dd47https://www.igj.nl/documenten/fsn-2026/04/01/edwards-lifesciences-llc-fca-198-swan-ganz-catheterThere have been a growing number of complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on Swan-Ganz catheters this may lead to infection, medication loss, and/or blood loss. Wed, 01 Apr 2026 10:47:00 GMTdoc-69ccfa66bc0d16c3810104e6https://www.igj.nl/documenten/fsn-2026/04/01/boston-scientific-corporation-97125289h-fa-accolade-serie-en-de-populatie-uitbreiding-van-dr-el--en-crt-pU ontvangt deze brief om u te informeren dat de bijgewerkte software, Brady software maintenance release 6 (SMR6), nu beschikbaar is voor pacemakers uit de ACCOLADE™-serie en pacemakers voor cardiale resynchronisatietherapie (CRT-P's)1 en dat de...Wed, 01 Apr 2026 09:05:00 GMTdoc-69cce22661eb45636b039c0bhttps://www.igj.nl/documenten/fsn-2026/04/01/getinge-sterilization-ab-ot-1480818-hs66-hs66-t-hs66-ltsf-hs66l-ge-small-gee-gev-small-gec-smallGetinge Sterilization AB received a report of a user injury involving the autoclave door.Wed, 01 Apr 2026 07:25:00 GMTdoc-69ccc963bc0d162910009dd8https://www.igj.nl/documenten/fsn-2026/03/31/edwards-lifesciences-llc-fca-196-evoque-tricuspid-delivery-systemIn het kader van het toezicht na het in de handel brengen, vanaf 13 februari 2026, hebben we een klachtenpercentage van 0,53% waargenomen waarbij sommige artsen weerstand ondervonden bij het draaien van de kapselknop en/of moeite of onvermogen om...Tue, 31 Mar 2026 13:35:00 GMTdoc-69cbd3dc61eb45fd5b02b1bdhttps://www.igj.nl/documenten/fsn-2026/03/30/integra-lifesciences-ireland-limited-2026-hhe-002-cusa-clarity-consoleHet probleem met deze versie van de software was dat het aanraakscherm van de CUSA® Clarity Console ongeveer 8 minuten na het opstarten niet meer reageert, wat ongeveer 28 dagen na de installatie van de genoemde software begint.Mon, 30 Mar 2026 13:57:00 GMTdoc-69ca8301bc0d1643d2ffa59fhttps://www.igj.nl/documenten/fsn-2026/03/30/laboratoires-anios-an-fsca-016-anios-clean-excel-dIt has been identified that certain products were distributed in Germany, Switzerland and Netherlands without labels including all required official local languages.Mon, 30 Mar 2026 13:20:00 GMTdoc-69ca7ad8bc0d16a7eeffa3d4https://www.igj.nl/documenten/fsn-2026/03/30/pathofinder-b.v.-fsca-2026-005-realaccurate-quadruplex-bordetella-pcr-kitThe external product label of the RealAccurate® Quadruplex Parainfluenza PCR kit (catalogue number PF0975-R) with lot number L2025003, sold after 22-05-2025, incorrectly referenced the IVDR notified body code next to the CE mark, whereas the...Mon, 30 Mar 2026 09:42:00 GMTdoc-69ca4769bc0d164855ff99c0