Bilirubin (total And Unbound) In The Neonate Test System
Clinical Chemistry · 21 CFR 862.1113
Recent MDR events
72 adverse event reports on file
- JAUNDICE - JM103/105Mar 6, 2025Malfunction1220063-2025-00018
- JAUNDICE JM105Feb 21, 2025MalfunctionDraeger Medical Systems, Inc.1220063-2025-00014
- JAUNDICE - JM105Oct 18, 2024MalfunctionDraeger Medical Systems, Inc2510954-2024-00046
- JAUNDICE - JM105Oct 10, 2024MalfunctionDraeger Medical Systems, Inc2510954-2024-00045
- JAUNDICE - JM105Oct 9, 2024MalfunctionDraeger Medical Systems, Inc2510954-2024-00044
- JAUNDICE JM105Sep 18, 2024MalfunctionDraeger Medical Systems, Inc.2510954-2024-00039
- JAUNDICE JM105Sep 18, 2024MalfunctionDraeger Medical Systems, Inc2510954-2024-00040
- JAUNDICE JM105Sep 18, 2024MalfunctionDraeger Medical Systems, Inc2510954-2024-00041
- JAUNDICE JM105Sep 18, 2024MalfunctionDraeger Medical Systems, Inc2510954-2024-00042
- JAUNDICE JM105Jul 29, 2024MalfunctionDraeger Medical Systems, Inc2510954-2024-00034
Event type breakdown
Recalls
6 recall events for this product code
- Draeger Medical Systems, Inc.TerminatedJun 7, 2018
Draeger Jaundice Meter JM-103
Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
Z-2046-2018 · View FDA record ↗ - Draeger Medical Systems, Inc.TerminatedJun 7, 2018
Draeger Jaundice Meter JM-105
Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
Z-2047-2018 · View FDA record ↗ - Siemens Healthcare Diagnostics IncTerminatedMar 6, 2015
RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784.
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.
Z-1252-2015 · View FDA record ↗ - Siemens Healthcare Diagnostics IncTerminatedMar 6, 2015
RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306.
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.
Z-1253-2015 · View FDA record ↗ - Siemens Healthcare Diagnostics IncTerminatedMar 6, 2015
RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179.
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.
Z-1254-2015 · View FDA record ↗ - Siemens Healthcare Diagnostics IncTerminatedMar 6, 2015
RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524.
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.
Z-1255-2015 · View FDA record ↗
Registered firms
65 firms currently registered for this product code
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Cbr Enterprise Limited
Hong Kong, HK
Zapalign Llc
Fort Lauderdale, FL, US
Instrumentation Laboratory Co.
Bedford, MA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Abbott Gmbh
Wiesbaden Hesse, DE
Radiometer Solutions Sp. Z O.o.
Stargard Zachodniopomorskie, PL
Nova Biomedical Corporation
WALTHAM, MA, US
Sekisui Diagnostics P.e.i. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Platinum Focus Group Ltd.
London London, City of, GB
Siemens Healthcare Diagnostics Inc
East Walpole, MA, US
Philips Medical Systems Ltda
Varginha Minas Gerais, BR
Respironics Inc.
MURRYSVILLE, PA, US
Abbott Laboratories
Irving, TX, US
Radiometer Medical Aps
BROENSHOEJ Hovedstaden, DK
Philips North America Llc
ANDOVER, MA, US
Radiometer Sp. Z O.o
Stargard Zachodniopomorskie, PL
510(k) clearances
17 clearances for this product code
- Radiometer Medical ApsApr 28, 2017
K170882 · ABL90 FLEX, ABL90 FLEX PLUS
- Draeger Medical Systems, Inc.Nov 13, 2014
K133175 · DRAEGER JAUNDICE METER JM-105
- Radiometer Medical ApsNov 13, 2014
K132691 · ABL90 FLEX
- Siemens Healthcare DiagnosticsAug 15, 2011
K110277 · RAPIDPOINT 405 NEONATAL BILIRUBIN
- Siemens Medical Solutions DiagnosticsJun 27, 2008
K073537 · NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
- Draeger Medical Infant Care, Inc.Jul 6, 2005
K042522 · JAUNDICE METER, MODEL JM 103
- Roche Diagnostics Corp.May 14, 2004
K040174 · BILIRUBIN ASSAY ON THE OMNI S ANALYZER
- Hill-Rom Air-ShieldsApr 1, 2003
K021622 · HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103