FDA Device recall Z-1370-2026
Medica Capillary Tubes
- FDA Device
- Class II
- ongoing
- Published 2026-02-25
On 2026-02-25 the FDA classified a Class II recall of Medica Capillary Tubes by Medica, citing A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1370-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-31 |
| Published | 2026-02-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medica |
| Distribution | n/a |
Product
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Reason
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Identifiers
| code_info | Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1370-2026%22
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