ABL90 Flex, Clot Catcher
ABL90 FLEX, Clot catcher, box of 250 pcs.
1manufacturer
1catalogue number
13510(k) clearances naming this product code
14recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Radiometer Medical APS, Denmark |
|---|---|
| FDA product code | CHL |
| Device type | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1120 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2016-09-01 |
| Record revised | 2026-05-29 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 906-026 | 250 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 80 |
| ABL80 SC80 | Radiometer Medical APS | 66 |
| ABL77 Sci | Radiometer Medical APS | 14 |
| Electrode for ABL analyzers | Radiometer Medical APS | 7 |
| Calibration Solution | Radiometer Medical APS | 7 |
| i-STAT | Abbott Point OF Care Inc. | 6 |
| ABL90 Sensor Cassette pack | Radiometer Medical APS | 6 |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests) | Instrumentation Laboratory SPA | 5 |
| Nova | Nova Biomedical Corporation | 4 |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 150 Tests) | Instrumentation Laboratory SPA | 4 |
| Calibration Gas 2 | Radiometer Medical APS | 3 |
| Ready Sensor™ Lactate Biosensor | Siemens Healthcare Diagnostics Inc | 3 |
Showing 12 of 235. All products under Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160153 | 2016-11-04 |
| K142898 | 2015-06-17 |
| K131988 | 2013-09-17 |
| K130144 | 2013-07-31 |
| K123748 | 2013-05-07 |
| K122729 | 2012-11-16 |
| K122642 | 2012-10-26 |
| K120197 | 2012-03-19 |
| K111897 | 2011-07-19 |
| K110416 | 2011-03-24 |
| K100777 | 2010-12-10 |
| K043218 | 2005-05-10 |
| K041874 | 2004-10-08 |
Recalls
14 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-03-21 | Class II | Component design/selection | ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (w | 6275 analyzers | |
| 2024-05-31 | Class II | Nonconforming Material/Component | 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 probability of reporting biased out-of-specifi | 27,127 analyzers | |
| 2022-05-18 | Class II | Software design | There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. | 1489 analyzers | |
| 2021-04-14 | Class II | Device Design | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Total=4,135 analyzers world-wide (only 1277 analyzers within | |
| 2020-05-26 | Class II | Software design | Potential risk of patient mix-up on analyzers due to software issues. | 3,899 units | 2023-02-08 |
| 2020-05-26 | Class II | Software design | Potential risk of patient mix-up on analyzers due to software issues. | 4,615 units | 2023-02-08 |
| 2020-05-11 | Class II | Under Investigation by firm | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accessi | 1981 | 2023-02-24 |
| 2020-05-11 | Class II | Under Investigation by firm | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accessi | 9373 units | 2023-02-24 |
| 2020-03-10 | Class II | Software design | 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 in patient mixup or loss of sample res | 3,656 units | 2022-10-31 |
| 2020-03-06 | Class II | Component design/selection | 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 in a delay in treatment. The delay could | 2 units | |
| 2020-02-03 | Class II | Software design | The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. T | 3,968 units | 2022-09-20 |
| 2019-11-21 | Class II | Nonconforming Material/Component | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted | 544 | 2024-11-08 |
| 2019-11-21 | Class II | Nonconforming Material/Component | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted | 1233 units | 2024-11-08 |
| 2018-02-27 | Class II | Device Design | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up. | 2 | 2019-03-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.