FDA Device recall Z-1462-2017
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oxim…
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oxim… 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-1462-2017 |
| 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
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
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-1462-2017%22
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