Radioimmunoassay, 17-hydroxyprogesterone
Clinical Chemistry · 21 CFR 862.1395
Recent MDR events
7 adverse event reports on file
- PROG II ST AIA-PACKDec 9, 2021MalfunctionTosoh Aia, Inc.9612316-2021-00002
- IMMULITE 2000Feb 20, 2015MalfunctionSiemens Healthcare Diagnostics Inc.2247117-2015-00006
- IMMULITE 2000Jan 2, 2015MalfunctionSiemens Healtchcare Diagnostics Inc2247117-2015-00001
- ADVIA CENTAUR XPOct 18, 2014MalfunctionSiemens Healthcare Diagnostics, Inc.2432235-2014-00607
- AUTODELFIA NEONATAL 17A-OH-PROGESTERONEMar 6, 2009OtherWallac Oy, Perkinelmer Las8043909-2009-00001
- IMMULITE 1000, PROGESTERONEJun 24, 2008OtherSiemens Healthcare Diagnostics2017183-2008-00022
- AUTODELFIA NEONATAL 17A-OH-PROGESTERONEDec 8, 2006OtherWallac Oy8043909-2006-00001
Event type breakdown
Recalls
3 recall events for this product code
- DRG International, Inc.Open, ClassifiedOct 29, 2024
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plas
The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.
Z-0258-2025 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedMay 25, 2023
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL)
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
Z-1631-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedMay 25, 2023
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal
Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
Z-1632-2023 · View FDA record ↗
Registered firms
28 firms currently registered for this product code
Euroimmun Us Inc.
Mountain Lakes, NJ, US
American Laboratory Products Company
Salem, NH, US
Tecan Trading Ag
Maennedorf Zurich, CH
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Tosoh Corp.
Chuo-ku Tokyo, JP
Tosoh Bioscience, Inc.
Grove City, OH, US
Ibl International Gmbh
HAMBURG, DE
Demeditec Diagnostics Gmbh
KIEL-WELLSEE Schleswig-Holstein, DE
Astoria-pacific, Inc.
Clackamas, OR, US
Immuno-biological Laboratories, Inc.
Fridley, MN, US
Drg International, Inc.
Springfield, NJ, US
Drg Instruments Gmbh
MARBURG Hesse, DE
Wallac Oy
TURKU Varsinais-Suomi, FI
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Monobind, Inc.
Lake Forest, CA, US
Diagnostics Biochem Canada, Inc.
London Ontario, CA
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Immunocentrix Corporation
Canoga Park, CA, US
510(k) clearances
19 clearances for this product code
- Wallac OYJul 23, 2010
K100682 · GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
- Wallac OYApr 16, 2009
K081922 · AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
- Drg Intl., Inc.Jan 29, 2008
K062534 · ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
- Neo-GenesisMar 13, 2007
K060452 · ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
- Wallac OYJul 11, 2005
K050960 · MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
- Wallac OYSep 30, 2004
K042424 · DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
- Wallac OYSep 30, 2004
K042425 · AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
- Bio-RadFeb 9, 1998
K973350 · BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST