FDA recall Z-3031-2026

Healthmark Industries Co., Inc. · Class II · device

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.

Key facts

Status
Ongoing
Initiation date
2026-07-29
Report date
2026-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fraser, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3031-2026