Official recall notice
FDA DeviceClass IINotable
healthmark ProChek-W Protein Test Recall (Sep 2026)
Product: healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
- Recall date
- 2026-09-02
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Product description
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Affected products
Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.