Healthmark Industries Co., Inc.: Healthmark Prochek-ii, Model Number Pt-313, Pt-201-12
Recall Summary Healthmark Industries is recalling its ProChek-II test kits (models PT-313 and PT-201-12) distributed nationwide in the US and in Canada, France, Hong Kong, and South Korea. The kits were manufactured with an expired ingredient that can cause inaccurate results, showing either false negatives or false positives. This is a Class II recall affecting a medical device.
- Recalling firm
- Healthmark Industries Co., Inc.
- Product
- healthmark ProChek-II, Model Number PT-313, PT-201-12
- Reason
- Test manufactured with an expired ingredient which may present as either a false negative or positive.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-29
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/786eb2c8-25ff-4290-a40a-dcd8611b9a0b