TemporaryFDAOngoing
Can cause harm that is usually temporary.
healthmark ProChek-II, Model Number PT-313, PT-201-12
Check the device or its packaging for
PT-313 - Serial/Lot Numbers: 3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 3000545623, 3000550099, 3000550512, 313069, 313072, 313073, 313074, 313075, 313076, 313077, 313078, 313079, 313080, 313081, 313082, 313083, 313084, 313085, 313086, 313087, 313088, 313089, 313090, 313091, 313092, 313093, 313094, 313095, 313096, 313097, 313098, 313099, 313100, 313101, 313102, 313106, 313107; H-PT-201-12 - Serial/Lot Numbers: 7P0110, 7P0111, 7P0113, 7P0122.
- Why
- Test manufactured with an expired ingredient which may present as either a false negative or positive.
- Distributed
- Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
- Company
- Healthmark Industries Co., Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3031-2026 · retrieved 26 August 2026
Read the official notice