FDA Device recall Z-2426-2024
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for…
- FDA Device
- Class II
- ongoing
- Published 2024-07-31
On 2024-07-31 the FDA classified a Class II recall of ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for… by Radiometer Medical Aps, citing 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 ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2426-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-31 |
| Published | 2024-07-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Radiometer Medical Aps |
| Distribution | US |
Product
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.
Reason
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-specification pH results on blood samples.
Identifiers
| code_info | Model Numbers: 393-800 and 393-801 Part Numbers/Serial Numbers/UDI(-DI) codes: ABL825 754R0100N003 754R0100N003 ABL825…Model Numbers: 393-800 and 393-801 Part Numbers/Serial Numbers/UDI(-DI) codes: ABL825 754R0100N003 754R0100N003 ABL825 754R0241N010 754R0241N010 ABL825 754R0334N006 754R0334N006 ABL825 754R0417N008 754R0417N008 ABL825 754R0449N004 754R0449N004 ABL825 754R0487N004 754R0487N004 ABL837 754R0631N006 754R0631N006 ABL825 754R0755N003 754R0755N003 ABL825 754R0757N007 754R0757N007 ABL825 754R0884N007 754R0884N007 ABL825 754R0917N002 754R0917N002 ABL825 754R0918N007 754R0918N007 ABL810 754R0941N008 754R0941N008 ABL827 754R1001N004 (01)05700693938004(10)754R1001N004 ABL805 754R1028N005 754R1028N005 ABL825 754R1105N005 754R1105N005 ABL825 754R1157N006 754R1157N006 ABL825 754R1204N006 754R1204N006 ABL805 754R1209N005 754R1209N005 ABL825 754R1220N003 754R1220N003 ABL805 754R1222N005 754R1222N005 ABL805 754R1222N006 754R1222N006 ABL825 754R1222N009 754R1222N009 ABL825 754R1223N008 754R1223N008 ABL805 754R1226N007 754R1226N007 ABL825 754R1234N003 754R1234N003 ABL825 754R1238N009 754R1238N009 ABL825 7 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2426-2024%22
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