[pending] Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Pending LLM rewrite. Source: FDA_DEVICE Z-1370-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
- Manufacturer
- Medica Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 7303
- UDI-DI: 00840095607575
- Lot No. 25XXX.
Distribution
Distribution scope not specified by the agency.
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