FDA Device recall Z-1321-2022
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
- FDA Device
- Class II
- ongoing
- Published 2022-07-13
On 2022-07-13 the FDA classified a Class II recall of ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 by Radiometer Medical Aps, citing there is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1321-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-18 |
| Published | 2022-07-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Radiometer Medical Aps |
| Distribution | US |
Product
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Reason
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Identifiers
| code_info | All ABL800 Flex Analyzers containing software versions below V6.19 MR2; UDI/DI ABL810, 820, and 830, ABL805, ABL815, A…All ABL800 Flex Analyzers containing software versions below V6.19 MR2; UDI/DI ABL810, 820, and 830, ABL805, ABL815, ABL825, ABL835: 05700693938004 ; UDI/DI ABL817, ABL827, ABL837: 05700693938011 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1321-2022%22
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