Z-1370-2026 Class II Ongoing
FDA device recall Z-1370-2026 was initiated by Medica Corporation on December 31, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1,578 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2026
- Initiation Date
- December 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,578 units
Product Description
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
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.
Distribution Pattern
International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
Code Information
Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.