Medica Corporation Recalls Capillary Tube Kits Due to Inaccurate Potassium Results

FDA Recalls high FDA · · International

Medica Corporation has recalled 1,578 Capillary Tube Kits because of a defect causing falsely elevated potassium readings, which could lead to incorrect medical treatments.

What Happened

Medica Corporation has initiated a voluntary recall of its capillary tubes used in EasyBloodGas and EasyStat kits. The recall was prompted by the discovery of a systematic positive bias of up to 20% across the reportable potassium range. This defect results in falsely elevated potassium readings for patient samples.

Which Products Are Affected

The recall involves 1,578 units of the following products:

  • Product Name: Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit
  • Model Number: 7303
  • UDI-DI: 00840095607575
  • Lot Number: 25XXX
  • Recall Number: Z-1370-2026

While the firm is based in Bedford, Massachusetts, the affected units were distributed internationally to Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, and Belarus.

What You Should Do

Medica Corporation initiated the recall notification via letter on December 31, 2025. Healthcare providers and distributors in possession of these kits should immediately follow the instructions provided in the notification letter from Medica Corporation. For inquiries, the company is located at 5 Oak Park Dr, Bedford, MA 01730.

Why This Matters

Inaccurate potassium measurements can lead to clinical misinterpretation and inappropriate medical interventions. A 20% positive bias poses a significant risk to patient safety by potentially masking true potassium levels or indicating hyperkalemia where it does not exist, leading to unnecessary or dangerous treatments.

Source

This information is based on official recall data provided by the FDA.

Source: FDA Official Notice