215 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JZO·February 23, 2012
Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700).
FDA Recall
Terminated
·Diasorin Inc.·Product code JZO·April 12, 2004
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code JZO·August 20, 2020
AIA-PACK TgAb CONTROL SET
FDA Recall
Terminated
·Tosoh Bioscience, Inc.·Product code JZO·February 8, 2017
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018
AIA-PACK TPOAb CONTROL SET
FDA Recall
Terminated
·Tosoh Bioscience, Inc.·Product code JZO·February 8, 2017
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JZO·December 7, 2018
DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
EDI BZO Uncut Sheet - Cup*, Item No. 160170
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
BZO Strip Dip Card (300ng/ml)*, Item No. 100170
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO
FDA Recall
Terminated
·Ameditech Inc·Product code DKC·August 18, 2020
ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
1 Step 12 Panel Cup, Item No. NBCA-12M-W
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015