healthmark ProChek-W Protein Test for Robotic Arms recall (Healthmark Industries Co., Inc.)
Medical deviceClass IIOngoing
Summary: Healthmark Industries Co., Inc. is recalling healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001. Reason: Test manufactured with an expired ingredient which may present as either a false negative or positive.
What is being recalled
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Why
Test manufactured with an expired ingredient which may present as either a false negative or positive.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
How to tell if yours is affected
Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3032-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 29, 2026 |
| Reported | September 2, 2026 |
| Company | Healthmark Industries Co., Inc. |
| Company location | Fraser, MI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 53 units |
More recalls from Healthmark Industries Co., Inc. · all medical device recalls · recalls from July 2026