Z-3031-2026 Class II Ongoing
FDA device recall Z-3031-2026 was initiated by Healthmark Industries Co., Inc. on July 29, 2026 and is designated Class II. Reason for recall: Test manufactured with an expired ingredient which may present as either a false negative or positive. The recall status is ongoing. Affected quantity: 5090 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- July 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5090 units
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Code Information
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.