FDA-Device2026-09-02Class IIPROCESSING DEFECT
Healthmark ProChek Protein Tests recalled for expired ingredient causing inaccurate results
What this means
Healthmark Industries' ProChek-W and ProChek-Semi protein tests were manufactured with an expired ingredient. This may cause the tests to show false negative or false positive results, meaning they could incorrectly indicate protein presence or absence.
- Check if you have a ProChek test with lot numbers 200035–200040 or 30028.
- Do not use affected tests. Contact Healthmark Industries for instructions on replacement or return.
- If you have already used an affected test, review those results with the appropriate personnel or clinician.
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
53 units
Manufactured in
18600 Malyn Blvd, N/A, Fraser, MI, United States
Products
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3032-2026More Healthmark Industries recalls
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