FDA DevicesClass II
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Published: February 25, 2026Recall ID: Z-1370-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Additional Source Details
| Field | Value |
|---|---|
| City | Bedford |
| State | MA |
| Event id | 98315 |
| Address 1 | 5 Oak Park Dr |
| Code info | Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX. |
| Postal code | 01730-1430 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 1,578 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251231 |
| Initial firm notification | Letter |
| Center classification date | 20260213 |
Overview
- Recalling FirmMedica Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.