FDAFDA · Food and drugs·Recall number Z-3031-2026
healthmark ProChek-II, Model Number PT-313, PT-201-12
Published September 2, 2026 · Recall initiated: July 29, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Test manufactured with an expired ingredient which may present as either a false negative or positive.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Healthmark Industries Co., Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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