FDAFDA recall Z-3031-2026 · Sep 2, 2026
Healthmark Industries Co., Inc.: healthmark ProChek-II recall
Recall found
Product
healthmark ProChek-II, Model Number PT-313, PT-201-12
Reason for recall
Test manufactured with an expired ingredient which may present as either a false negative or positive.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 5090 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
- Recalling firm
- Healthmark Industries Co., Inc., Fraser, MI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-29
Source: openFDA enforcement record Z-3031-2026 · search recall number Z-3031-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.