Brea, CA, United States
Radiometer America Inc recalls
4 recalls recorded since 2018, most recently on 10 July 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 July 2019
- Terminated
- 13 June 2022
- 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 treatment.
- Distribution
- US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Austral
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2320-2019
- ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Terminated Class II Medical devices
- Recall started
- 3 July 2018
- Terminated
- 30 August 2023
- Reason
- The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
- Distribution
- Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0682-2019
- ABL800 analyzer, model numbers 393-800 and 393-801.
Terminated Class II Medical devices
- Recall started
- 2 July 2018
- Terminated
- 2 April 2024
- 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 up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine.
- Distribution
- US: AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WA, WI, and WV OUS: Canada, Croatia, Finland and Russia
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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,
Terminated Class II Medical devices
- Recall started
- 25 May 2018
- Terminated
- 6 November 2020
- 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 ¿ Immediately after lifts the inlet and quickly closes it again
- Distribution
- US Distribution and Internationally to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.