24 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
FDA Recall
Terminated
·Hologic, Inc·Product code NUA·March 31, 2016
CF InPlex ASR Card; Catalog Number: 95-0501.
FDA Recall
Terminated
·Hologic, Inc·Product code NUA·March 31, 2016
Toshiba DUA-450F Kalare Radiographic Tilting Table.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IXR·July 15, 2010
X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code rad·September 7, 2004
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code QLT·November 8, 2021
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·January 12, 2022
ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code LTJ·August 9, 2016
ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.
FDA Recall
Terminated
·Alung Technologies Inc·Product code QLN·December 18, 2020
ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.
FDA Enforcement
Class II
·Terminated·Alung Technologies Inc·February 10, 2021
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
FDA Recall
Terminated
·Ortho Clinical Diagnostics Inc·Product code QMN·September 30, 2020
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics Inc·November 25, 2020
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
FDA Recall
Terminated
·LumiraDx·Product code QKP·September 23, 2022
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code QLT·July 15, 2020
Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.
FDA Recall
Terminated
·Bausch and Lomb, Incorporated·Product code NAA·November 14, 2011
Achilles Express Bone Sonometer
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MUA·September 3, 2019
Achilles Insight Bone Sonometer
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MUA·September 3, 2019
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
FDA Recall
Terminated
·LumiraDx·Product code QKP·January 11, 2021
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·September 16, 2020
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
FDA Enforcement
Class III
·Terminated·LumiraDx·November 2, 2022
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
FDA Enforcement
Class II
·Terminated·LumiraDx·February 24, 2021