FDA-Device2026-09-02Class IIPROCESSING DEFECT
Healthmark ProChek-II sterilization test recalled for expired ingredient causing inaccurate results
What this means
Healthmark Industries' ProChek-II sterilization tests (models PT-313 and PT-201-12) were manufactured with an expired ingredient. This ingredient may cause the test to give a false negative or false positive result, meaning a sterilizer could appear to be working correctly when it is not, or vice versa.
- Check if your ProChek-II test kit matches one of the affected lot numbers listed in the recall.
- Do not rely on affected test kits to verify sterilization equipment.
- Contact Healthmark Industries or the FDA for instructions on returning or replacing your kit.
- If you have used an affected kit to validate sterilization, contact your equipment supplier to retest.
The agency's original wording
Hazard
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Affected count
5090 units
Manufactured in
18600 Malyn Blvd, N/A, Fraser, MI, United States
Products
healthmark ProChek-II, Model Number PT-313, PT-201-12
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3031-2026More Healthmark Industries recalls
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