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vrijdag 12 oktober 2018

IGJ waarschuwingen: Lohmann & Rauscher, Raucodrape Camera Drape

Lohmann & Rauscher, Raucodrape Camera Drape
Due to feedback from the market, the Raucodrape camera cover was checked and in some cases leakages (small holes) were detected.
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Abbott, Alinity i Processing Module
The issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution(s) that eventually results in the pump failure.
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Bio-Rad, Pastorex Meningitis
Recent customer complaints concerning unusual high rates of positive agglutination with the R4 reagent, Streptococcus.pneumoniae latex, not confirmed by another technique raised our concern on the product.
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Siemens Healthcare, Dimension Vista Lipase
Siemens Healthcare Diagnostics has confirmed lot-to-lot variability for QC and patient results when using the Dimension Vista® LIPL lots listed in Table 1.
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ELITechGroup B.V., V-Twin
The reagent cooling indicator board of the V-Twin was not connected correctly.
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