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4.010 publicaties
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Accelerate Diagnostics, Inc., 3010671651-101722-001-C-EU, Accelerate PhenoTest BC Kit
Accelerate Diagnostics, Inc. is aware of North American complaints concerning false positive identification results for ...
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Siemens Healthcare Diagnostics Inc., IMC 23-01, IMMULITE
The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide ...
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ELITECH CLINICAL SYSTEMS SAS, 2202VIG01, MAGNESIUM XB
This letter is to notify you that the linearity claims of MAGNESIUM XB (ref. MGXB-0250, MGXB-0600 and MGXB-M430) may not be met. ...
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Ventana Medical Systems Inc., SBN PathologyLab2022 006 VENTANA PD L1 P142, VENTANA
VENTANA Medical Systems, Inc. (Roche) observed unacceptable, light staining with some VENTANA PD-L1 (SP142) on-market lots, ...
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Teleflex Medical Europe, EIF-000521, RUSCH Ureteral Catheters; RUSCH Superglide Integal Plus; RUSCH Valve Uretheral Stents; RUSCH Valve DD Uretheral Stents
Teleflex Medical Europe Limited, heeft een vrijwillige corrigerende veiligheidsactie ('FSCA') opgezet voor de hierboven vermelde ...
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Abbott Molecular, Inc., FSN-FA-AM-OCT2022-282, Alinity m System
This letter contains important information regarding your Alinity m System; Specifically, the current software installed on your ...
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Advance Medical Designs Inc, FSN-22.006, Needle Guides and Grids
This letter is meant to serve as notification to your company making you aware of a voluntary recall being conducted by Advance ...
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Leica Biosystems Newcastle, IR 64/22, BOND tm Ready-to-Use Primary Antibody Bcl-6 (LN22)
Ieica Brosystems Newcastle recently became aware that due to an error, tlîe affected device mentioned above has been assigned an ...
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Samenwerkingsprotocol gezondheidszorg IGJ en OM 2021
Samenwerkingsprotocol tussen de Inspectie voor de Gezondheidszorg en en Jeugd (IGJ) en het Openbaar Ministerie (OM).
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3M Company, 2022-11 FSCA Ranger, Blood Fluid Warming High Flow Sets
This corrective action has been initiated due to the identification of a manufacturing issue with the auto-venting bubble trap. ...