Radiometer America recalls
Radiometer America appears in 25 official U.S. recall notices indexed by RecallRadar, most recently on 2019-08-28.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 25 |
|---|---|
| Published | 2012-08-15 to 2019-08-28 |
| By agency | FDA Device (25) |
| By classification | Class II (24), Class III (1) |
| By status | terminated (25) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, US, UT, VA, VT, WA, WI, WV |
Recalls
- ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
FDA Device · Class II · 2019-08-28 · Radiometer America
Reason: Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical trea… - Product: ABL800 FLEX with Crea
FDA Device · Class II · 2019-02-13 · Radiometer America
Reason: From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with… - ABL800 analyzer, model numbers 393-800 and 393-801
FDA Device · Class II · 2019-01-02 · Radiometer America
Reason: The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. - ABL90 FLEX analyzers with software versions 3.3MR1 or below
FDA Device · Class II · 2018-10-10 · Radiometer America
Reason: The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Imme… - ABL800 analyzer with FLEXQ module
FDA Device · Class II · 2017-12-20 · Radiometer America
Reason: Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer. - AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are…
FDA Device · Class II · 2017-10-11 · Radiometer America
Reason: Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the l… - The ABL800 Model#:All
FDA Device · Class II · 2017-03-22 · Radiometer America
Reason: Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous. - ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oxim…
FDA Device · Class II · 2017-03-22 · Radiometer America
Reason: Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous. - 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 Radi…
FDA Device · Class II · 2016-12-28 · Radiometer America
Reason: Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value. - TCM CombiM Modules 903-111
FDA Device · Class II · 2016-05-11 · Radiometer America
Reason: Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume. - AQURE System
FDA Device · Class II · 2016-02-10 · Radiometer America
Reason: The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could le… - Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873
FDA Device · Class II · 2015-08-26 · Radiometer America
Reason: When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring. - Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of s…
FDA Device · Class II · 2015-03-25 · Radiometer America
Reason: Negative drift on QC during in-use lifetime of CREA membranes can be observed. - ABL90 FLEX analyzer
FDA Device · Class II · 2015-02-11 · Radiometer America
Reason: The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result. - HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the…
FDA Device · Class II · 2014-12-31 · Radiometer America
Reason: Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversi… - RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, sto…
FDA Device · Class II · 2014-09-17 · Radiometer America - pCO2 D788 Membranes
FDA Device · Class II · 2014-03-05 · Radiometer America
Reason: RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. - ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, el…
FDA Device · Class II · 2014-01-29 · Radiometer America
Reason: RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results. - pO2 D999 membrane units
FDA Device · Class II · 2014-01-22 · Radiometer America
Reason: RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glyce… - Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood
FDA Device · Class II · 2013-10-09 · Radiometer America
Reason: RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane. - TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com
FDA Device · Class II · 2013-08-14 · Radiometer America
Reason: RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. - Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042
FDA Device · Class III · 2013-01-02 · Radiometer America
Reason: The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45. - The ABL software version 6.12 for the ABL800 and ABL700 analyzer
FDA Device · Class II · 2012-08-15 · Radiometer America
Reason: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broke… - ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood
FDA Device · Class II · 2012-08-15 · Radiometer America
Reason: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broke… - The ABL software version 6.12 for the ABL800 analyzer
FDA Device · Class II · 2012-08-15 · Radiometer America
Reason: A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broke…