# K041874: ABL800 Flex

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Oct 8, 2004 after 88 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K861087 (1986). 15 ancestors in all.
29 later devices descend from it; 6 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002290: Abl-700 Series, Model Abl 7XX (Various Models), Radiometer Medical A/S (2000) Summary page 1.
- K992859: ABL700 Series Analyzer with Autocheck Module, Radiometer America, Inc. (2000) Summary page 1.

## Most influential descendants
- K050869: Modification to ABL800 Flex (2005), 18 descendants of its own
- K092686: ABL90 Flex Series (2010), 12 descendants of its own
- K120197: ABL90 Flex (2012), 6 descendants of its own
- K122729: ABL90 Flex (2012), 5 descendants of its own
- K043218: ABL800 Flex with Flexq Module, Model ABL8XX (2005), 4 descendants of its own

## Recalls of this device
- Aug 18, 2026 · Class II · Z-0190-2027: In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing F
- May 31, 2024 · Class II · Z-2426-2024: Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probabi
- May 18, 2022 · Class II · Z-1321-2022: There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
- May 26, 2020 · Class II · Z-2494-2020: Potential risk of patient mix-up on analyzers due to software issues.
- May 26, 2020 · Class II · Z-2493-2020: Potential risk of patient mix-up on analyzers due to software issues.
- Mar 10, 2020 · Class II · Z-1684-2020: Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result
- Mar 6, 2020 · Class II · Z-1836-2020: Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting 
- Jul 3, 2018 · Class II · Z-0682-2019: The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
- Oct 24, 2017 · Class II · Z-0231-2018: 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 analyze
- Jan 26, 2017 · Class II · Z-1463-2017: Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
- Jul 5, 2013 · Class II · Z-1075-2014: RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
- Jul 5, 2012 · Class II · Z-2163-2012: 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 
- Jul 5, 2012 · Class II · Z-2162-2012: 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 
- Apr 16, 2009 · Not classified · Z-1554-2009: When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
- Jan 18, 2008 · Not classified · Z-1654-2008: Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause th
- Jun 22, 2007 · Not classified · Z-0038-2008: Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at 
- Nov 13, 2006 · Not classified · Z-1095-2007: Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the el
- Oct 31, 2005 · Not classified · Z-1325-06: ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
- Sep 29, 2005 · Not classified · Z-1387-06: Under certain circumstances, the ABL 700 &800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low
- Sep 19, 2005 · Not classified · Z-1324-06: Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
- Jun 17, 2005 · Not classified · Z-1318-06: Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.
- Jun 17, 2005 · Not classified · Z-1319-06: The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.

## Indications for use
The ABL800 FLEX is intended for in vitro testing of samples of whole blood for the parameters pH, PO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for in vitro testing of samples of expired air for the parameters PO2 and PCO2. The ABL800 FLEX includes an AutoCheck Module to perform automated analysis of quality control fluids.

Source page: https://510kreport.com/device/K041874
Methodology: https://510kreport.com/methodology