Radiometer America Inc
FDA Regulatory Profile
Radiometer America Inc appears in FDA public data with 25 recalls, 50 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2320-2019, Class II) was initiated on July 10, 2019. Its most recent 510(k) clearance was granted on January 28, 2016.
Summary
- Total Recalls
- 25
- 510(k) Clearances
- 50
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2320-2019 | Class II | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | July 10, 2019 |
| Z-0682-2019 | Class II | ABL800 analyzer, model numbers 393-800 and 393-801. | July 3, 2018 |
| Z-0801-2019 | Class II | Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: A | July 2, 2018 |
| Z-0010-2019 | Class II | ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, | May 25, 2018 |
| Z-0231-2018 | Class II | ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood | October 24, 2017 |
| Z-3237-2017 | Class II | AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALIC | September 7, 2017 |
| Z-1463-2017 | Class II | The ABL800 Model#:All | January 26, 2017 |
| Z-1462-2017 | Class II | ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electro | January 26, 2017 |
| Z-0899-2017 | Class II | AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog | November 23, 2016 |
| Z-0748-2016 | Class II | AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. | December 29, 2015 |
| Z-1595-2016 | Class II | TCM CombiM Modules 903-111 | November 18, 2015 |
| Z-2417-2015 | Class II | Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit | July 16, 2015 |
| Z-1046-2015 | Class II | ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood g | December 8, 2014 |
| Z-1293-2015 | Class II | Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which | October 29, 2014 |
| Z-0873-2015 | Class II | HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with | October 20, 2014 |
| Z-2597-2014 | Class II | RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for cli | July 28, 2014 |
| Z-0816-2014 | Class II | ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated | October 15, 2013 |
| Z-1075-2014 | Class II | pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi- | July 5, 2013 |
| Z-0713-2014 | Class II | pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane u | June 10, 2013 |
| Z-1930-2013 | Class II | TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, | November 27, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Cre | January 28, 2016 |
| K992859 | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE | January 10, 2000 |
| K991417 | ABL 735 ANALYZER | November 24, 1999 |
| K982928 | NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM | January 6, 1999 |
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM | February 9, 1998 |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | January 28, 1998 |
| K974818 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | January 16, 1998 |
| K973367 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | October 6, 1997 |
| K962158 | PICO MODELS 30, 50, 70 | October 29, 1996 |
| K962334 | EML105 ELECTROLYTE METABOLITE ANALYZER | October 24, 1996 |
| K961355 | MULTICHECK | June 14, 1996 |
| K961354 | QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) | June 14, 1996 |
| K952725 | MULTICHECK | February 20, 1996 |
| K954612 | ABL SYSTEM 625, 615, 605 | November 9, 1995 |
| K952621 | EML105 ELECTROLYTE METABOLITE ANALYZER | October 17, 1995 |
| K951240 | JUSTONE | October 7, 1995 |
| K951241 | HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE | October 7, 1995 |
| K952637 | QUALICHECK 4 GLUCOSE | September 5, 1995 |
| K936305 | SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES | July 13, 1995 |
| K943882 | ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM | March 10, 1995 |