- Recalling firm
- Healthmark Industries Co., Inc.
- Reason for recall
- Test manufactured with an expired ingredient which may present as either a false negative or positive.
- Affected products (lot / model / serial)
- Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.
- Units affected
- 53 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
- Firm location
- Fraser, MI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3032-2026
- Recall initiated
- July 29, 2026
- FDA classification date
- August 26, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99537
- Last updated on HTM Vibe
- September 8, 2026