Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Alba Bioscience Limited (Ltd.), 00003-2023, ALBAcyte® Reagent Red Cells A1

   Investigations have identified that the product is mis-labeled in that one of the three units used to manufacture this reagent ...

   Waarschuwing | 31-08-2023

2. Alba Bioscience Limited (Ltd.), 00002-2023, ORTHO™ Sera Anti - Lea

   Een onderzoek naar aanleiding van klachten van klanten heeft bevestigd dat de genoemde partijen ORTHOTM Sera Anti-Lea onverwachte ...

   Waarschuwing | 29-08-2023

3. Diagnostic Grifols S.A., 800012097, ERYTRA EFLEXIS

   The analyzer may give incorrect interpretations of a profile that includes multiple techniques under certain conditions.

   Waarschuwing | 28-08-2023

4. Siemens Healthcare Diagnostics Inc., CHC 23-02, ADVIA Chemistry Iron_2 (IRON_2) Reagents

   Siemens Healthcare Diagnostics Inc. has confirmed, through investigation of customer complaints, the potential for a positive ...

   Waarschuwing | 28-08-2023

5. AB SCIEX Pte. Ltd., FSCA-2023-177083, 4500MD and Citrine LC-MS/MS Systems

   In rare occasions, the combination of a leak of a highly flammable solvent at the ion source pro be, and an electrical discharge ...

   Waarschuwing | 21-08-2023

6. Beckman Coulter, Inc., FA 23026, Access Folate (Reagent Pack)

   Beckman Coulter heeft vastgesteld dat de reagenspipetten voor de DxI 9000 Access-immunoassay-analyser mogelijk niet volledig door ...

   Waarschuwing | 21-08-2023

7. Siemens Healthcare Diagnostics Inc., CHC 23-01, ADVIA Chemistry Urinary.Cerebrospinal Fluid Protein

   Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

   Waarschuwing | 14-08-2023

8. BioMérieux SA, FSCA #5773, BK VIRUS R-GENE; EBV R-GENE

   Following complaints from the field related to low positive signals (aspecific signals below Ct corresponding to the limit of ...

   Waarschuwing | 03-08-2023

9. Randox Laboratories Ltd., FSN-REC679, LIQUID URINE CONTROL LEVEL 2

   Randox Laboratories is conducting a Device Recall for Liquid Urine Controls Level 2, UC5074, lot 1209UC due to the following:  ...

   Waarschuwing | 24-07-2023

10. ELITech Clinical Systems SAS, FSN-2306VIG01, LACTATE

    In extreme Lactic Acidosis, Lactate levels may rise to >5 mmol/L (45 mg/dL), hence the revised range, in combination with the ...

    Waarschuwing | 20-07-2023