FDA Device recall Z-1463-2017
The ABL800 Model#:All
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of The ABL800 Model#:All by Radiometer America, citing reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1463-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-26 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Radiometer America |
| Distribution | US |
Product
The ABL800 Model#:All
Reason
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Identifiers
| code_info | The affected analyzers are serial numbers 393-090R0027N001 to present. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1463-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.