Medica Corporation: Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medica Corporation
- Product
- Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
- Recall initiated
- 2025-12-31
- Code info
- Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.
- Product quantity
- 1,578 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bedford
- State
- MA
- Country
- United States
- Event id
- 98315
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