53 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·July 21, 2021
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·October 6, 2021
iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·October 20, 2015
iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
FDA Recall
Terminated
·Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munich Germany·Product code JJE·June 17, 2020
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Biomedical GmbH·September 30, 2020
Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."
FDA Recall
Terminated
·Ameditech Inc·Product code DIO·August 18, 2020
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·September 10, 2010
Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup¿ Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JPA·May 10, 2011