13 results
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35ms
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Sources: EU EUDAMED, US FDA
WEIL INDUSTRIES
Manufacturer
🇫🇷 France
WEIL INDUSTRIES
FDA registration
WEIL INDUSTRIES·1 product·🇫🇷 France
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices
API LISTERIA 10STRIPS+10MEDIA
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code JTO·October 10, 2023
API LISTERIA 10STRIPS+10MEDIA
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code JTO·October 10, 2023
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·March 16, 2022
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
FDA Recall
Open, Classified
·Envisiontec US Llc·Product code EBZ·January 20, 2022
Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·August 3, 2016
Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JQC·February 5, 2016
Meddevices Lifesciences B.V.
Authorized representative
🇳🇱 Netherlands·41 Manufacturers·2587 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
KTR Europe GmbH
Authorized representative
🇩🇪 Germany·135 Manufacturers·3461 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices