Radiometer America, Inc.
Radiometer America, Inc. holds FDA 510(k) medical device clearances, first cleared 1983, most recent 2016, with 25 FDA device recalls on record.
Top product codes for Radiometer America, Inc.
FDA recalls by Radiometer America, Inc.
10 most recent of 25- Z-2320-2019 — ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
- Z-0682-2019 — ABL800 analyzer, model numbers 393-800 and 393-801.
- Z-0801-2019 — Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845.
- Z-0010-2019 — ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.
- Z-0231-2018 — ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter
- Z-3237-2017 — AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
- Z-1462-2017 — ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
- Z-1463-2017 — The ABL800 Model#:All
- Z-0899-2017 — AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
- Z-0748-2016 — AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Radiometer America, Inc.
- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
- K991417 — ABL 735 ANALYZER
- K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
- K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
- K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
- K974818 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
- K973367 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
- K962158 — PICO MODELS 30, 50, 70
- K962334 — EML105 ELECTROLYTE METABOLITE ANALYZER
- K961354 — QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
- K961355 — MULTICHECK
- K952725 — MULTICHECK
- K954612 — ABL SYSTEM 625, 615, 605
- K952621 — EML105 ELECTROLYTE METABOLITE ANALYZER
- K951240 — JUSTONE
- K951241 — HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
- K952637 — QUALICHECK 4 GLUCOSE
- K936305 — SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
- K943882 — ABL5 BLOOD GAS SYSTEM; BPH5 BLOOD PH SYSTEM
- K944753 — SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
- K935121 — ABL SYSTEM 620
- K935655 — ABL5 BLOOD GAS SYSTEM
- K935120 — EML 100
- K935515 — MULTICHECK(TM)
- K935566 — SENSI-CAL AMCO AEPA-1
- K923045 — SENSITITRE SUSCEPTIBILITY PLATES
- K924802 — CALIBRATION VERIFICATION KIT OR CVK
- K923342 — MICROBACT SOLID PLATE SYSTEMS
- K922922 — ABL50 BLOOD GAS SYSTEM
- K912444 — MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
- K914166 — ABL505 BLOOD GAS & ELECTROLYTE SYSTEM
- K915399 — QUALICHECK 4
- K910827 — ABL520 BLOOD GAS SYSTEM
- K904513 — ABL510 BLOOD GAS SYSTEM
- K904733 — QUALICHECK 3
- K900333 — E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
- K896514 — QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
- K895181 — ABL500 BLOOD GAS SYSTEM
- K893587 — OXIMETER
- K894776 — SENSITITRE INDOLE REAGENT
- K894110 — QUALICHECK 2
- K890057 — SENSITITRE AUTO ID PLATE AP80
- K871353 — OXIMETER
- K860057 — ABL330 ACID BASE LABORATORY
- K853990 — OSM3 HEMOXIMETER
- K844295 — ABL300 ACID BASE LABORATORY
- K833696 — ACID BASE LABORATORY ABL4
- K831034 — QUALISTICK ARTERIAL BLOOD SAMPLER
- K830805 — KNAI SODIUM POTASSIUM ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.