Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
-
The Binding Site Group AE040 - VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay Kit
Er is een positieve vertekening geconstateerd bij de betreffende lots. De mate van vertekening verschilt per gebruikte ...
-
Biomatrica, 2019-001, LBgard Blood Collection Tube
A review of all data reports referenced in the Technical File for LBgard, along with data from additional studies performed after ...
-
Roche Diagnostics, CN-467273, AssayTip/AssayCup tray
Roche has identified AssayTips with abnormal internal structure in some lots.
-
Scimedx 19-02 - Scimedx Toxocara kit
This letter is to inform you that Scimedx Corporation initiated a recall to remove the following kit due to reduced sensitivity.
-
Luminex RC-19-007 - xTAG® RVP FAST v2 (Respiratory Viral Panel Fast v2)
A false negative result may occur when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. ...
-
Cell Marque Corporation 202013581 - KAPPA (EP171) RABBIT MONOCLONAL PRIMARY ANTIBODY
The labelling of the affected products does not accurately represent the content.
-
Siemens ASI 19-02 - Atellica® Solution
Siemens Healthcare Diagnostics, Inc. has confirmed that the Atellica CH 930 Analyzer may report incorrect serum indices for ...
-
The Binding Site Group Limited AE039 - Optilite IgM Kit
Uit een intern onderzoek bij The Binding Site (TBS) is gebleken dat sommige gebruikers problemen kunnen ondervinden wanneer zij ...
-
Becton Dickinson BDDS-19-1617 - BD Kiestra™ InoqulA+™ TLA
Op basis van klantenfeedback stelde BD vast dat een softwareprobleem onder specifieke omstandigheden een mismatch zou kunnen ...
-
Tem Innovations, 600000957, r ex-tem
We have received customer complaints on Lot No. 42255701 of ROTEM r ex-tem, reporting prolonged clotting times (CT) with multiple ...