FDA recall, , Moderate risk
Medica Capillary Tubes and EasyBloodGas/EasyStat Capillary Tube Kit
Medica Capillary Tubes can falsely elevate potassium results in patient samples.
Summary by Recall Canary from the FDA notice
What happened
Medica Corporation of Bedford, Massachusetts, recalled Medica Capillary Tubes, including the EasyBloodGas/EasyStat Capillary Tube Kit, because 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 the tubes.
The recall began December 31, 2025, and was added to the FDA's Enforcement Report on February 13, 2026. The 1,578 units were distributed internationally to Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, and Belarus.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
- UDI-DI
- 00840095607575
- Lot code
- 25XXX
Recall details
- Company began the recall
- Sold in
International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.
- Company
- Medica CorporationBedford, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98315
- Recall number
- Z-1370-2026
- Quantity recalled
- 1,578 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
