Recall Z-3031-2026— Healthmark Industries Co., Inc.
Class II · Ongoing
Class II FDA medical device recall by Healthmark Industries Co., Inc., initiated 2026-07-29. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Healthmark Industries Co., Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-29
- Firm location
- Fraser, MI, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.