Device recall
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
- Recall number
- Z-3032-2026
- 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
- 53 units
- Code info
- Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.
- 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