Healthmark ProChek-II: False Test Results Due to Expired Ingredient
Healthmark recalls ProChek-II devices with specific serial numbers due to expired ingredients causing false test results. Affected units may show inaccurate results, potentially leading to incorrect health decisions.
Lower-risk recall
Test manufactured with an expired ingredient which may present as either a false negative or positive.
What happened, in plain English
Healthmark is recalling ProChek-II devices with certain serial numbers because they were made with an expired ingredient. This could cause the device to give false positive or negative results, which might lead to incorrect health decisions. Read more at govinfonow.com/recall/697849-healthmark-prochek-ii-false-test-results-due-to-expired-ingredient.
Source Summary by GovInfoNow · govinfonow.com/recall/697849-healthmark-prochek-ii-false-test-results-due-to-expired-ingredient · Updated September 14, 2026 · FDA enforcement record: FDA #Z-3031-2026
Cite this page
“Healthmark ProChek-II: False Test Results Due to Expired Ingredient.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697849-healthmark-prochek-ii-false-test-results-due-to-expired-ingredient. Based on FDA recall #Z-3031-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3031-2026%22&limit=1).
Why it’s dangerous
The device uses an expired ingredient that can cause it to produce inaccurate test results. This means it might show a health condition is present when it isn't, or vice versa, leading to potential mismanagement of health issues.
Who’s affected
People who own or use Healthmark ProChek-II devices with the listed serial numbers are affected. Those relying on the device for health testing are most at risk.
How to tell if you have this one
Check the serial numbers on your Healthmark ProChek-II device. The affected units have specific serial numbers listed in the recall notice, including PT-313 and H-PT-201-12 models.
- Brand
Healthmark- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3031-2026 | healthmark ProChek-II, Model Number PT-313, PT-201-12; PT-313 - Serial/Lot Numbers: 3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 3000545623, 3000550099, 3000550512, 313069, 313072, 313073, 313074, 313075, 313076, 313077, 313078, 313079, 313080, 313081, 313082, 313083, 313084, 313085, 313086, 313087, 313088, 313089, 313090, 313091, 313092, 313093, 313094, 313095, 313096, 313097, 313098, 313099, 313100, 313101, 313102, 313106, 313107; H-PT-201-12 - Serial/Lot Numbers: 7P0110, 7P0111, 7P0113, 7P0122. | 5090 units |
| Z-3032-2026 | healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001; Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028. | 53 units |
What to do — step by step
Check Device Serial Number
Look for the serial number on your Healthmark ProChek-II device to see if it matches the listed numbers in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the affected device?
Check your device's serial number against the list provided in the recall notice to see if it's affected. If it is, you may need to contact Healthmark for further instructions.
Is there a risk of serious injury from this device?
The recall states the device may give inaccurate results, but there is no mention of physical injury risks. This is a low-risk issue related to test accuracy.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3031-2026 (July 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3031-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.