Ph Rate Measurement, Carbon-dioxide
Clinical Chemistry · 21 CFR 862.1160
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Beckman Coulter Inc.TerminatedMay 28, 2020
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide i
Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with changes in the body acid-base balance, has a low pH and may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results which can lead to delay in treatment.
Z-2136-2020 · View FDA record ↗ - Hospira IncTerminatedJan 27, 2005
The Hospira Plum A+ I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV set
The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
Z-0438-05 · View FDA record ↗ - Hospira IncTerminatedJan 27, 2005
The Hospira Plum A+3 I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV se
The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
Z-0439-05 · View FDA record ↗
Registered firms
30 firms currently registered for this product code
Diamond Diagnostics Inc.
Budapest, HU
Abbott Point Of Care Inc.
Princeton, NJ, US
Carolina Liquid Chemistries
Brea, CA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Abbott Point Of Care Canada Limited
Ottawa Ontario, CA
Nova Biomedical Corporation
WALTHAM, MA, US
Beckman Coulter, Inc.
BREA, CA, US
Epocal Inc
Ottawa Ontario, CA
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Epocal, Inc.
Ottawa Ontario, CA
Beckman Coulter, Inc.
CARLSBAD, CA, US
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
510(k) clearances
28 clearances for this product code
- Abbott Point of Care, Inc.Feb 7, 2020
K191298 · i-STAT CHEM8+ cartridge with the i-STAT 1 System
- Genchem, Inc.Dec 27, 2004
K040975 · GENCHEM CO2 ACID REAGENT
- Beckman Coulter, Inc.Dec 18, 2001
K014034 · MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
- Sigma Diagnostics, Inc.Oct 24, 1996
K963541 · SIGMA DIAGNOSTICS CO2 ACID REAGENT
- Sigma Diagnostics, Inc.Oct 11, 1996
K963538 · SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
- Sigma Diagnostics, Inc.Sep 27, 1996
K963540 · SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
- Nova Biomedical Corp.Aug 23, 1996
K963005 · NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
- Sigma Chemical Co.Jan 3, 1994
K933696 · SIGMA ELECTROLYTE REFERENCE REAGENT