Medica Corporation: Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

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.

Details from the source

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: International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus. Quantity: 1,578 units Lot/code info: Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.

UPC codes

00840095607575

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.