Drug recall
healthmark ProChek-II, Model Number PT-313, PT-201-12
FDA recall event 99537 · Class II · Healthmark Industries Co., Inc.
Key facts
| Event ID | 99537 |
|---|---|
| Recall numbers | Z-3031-2026, Z-3032-2026 |
| Recalling firm | Healthmark Industries Co., Inc. |
| Product type | Devices |
| Products | healthmark ProChek-II, Model Number PT-313, PT-201-12, healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Test manufactured with an expired ingredient which may present as either a false negative or positive. |
| Initiation date | Jul 29, 2026 |
| Report date | Sep 2, 2026 |
| City | Fraser |
| State | MI |
| Country | United States |
| FEI number | 1000160387 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: