Device recall
healthmark ProChek-II, Model Number PT-313, PT-201-12
- Recall number
- Z-3031-2026
- Event id
- 99537
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Healthmark Industries Co., Inc.
- Report date
- Sep 2, 2026
- Posted
- Aug 26, 2026
- Initiated
- Jul 29, 2026
- Center classification date
- Aug 26, 2026
- Product code
- SDC
- Device type
- Qualitative Cleaning Process Protein Indicator
- Reason
- Test manufactured with an expired ingredient which may present as either a false negative or positive.
- Root cause
- Under Investigation by firm
- Quantity
- 5090 units
- Code info
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Fraser, MI, United States