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MEDICAL DEVICE RECALLMODERATE
healthmark ProChek-II Test
Healthmark recalls ProChek-II tests (PT-313, PT-201-12) over expired ingredient risk.
What to do
Stop using the affected ProChek-II tests immediately. Contact Healthmark Industries for instructions on returning the product and obtaining a replacement.
Why it was recalled
Healthmark Industries is recalling ProChek-II tests, models PT-313 and PT-201-12, because they were manufactured with an expired ingredient, which may cause false negative or false positive results.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| healthmark ProChek-II, Model Number PT-313, PT-201-12 | 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 (+8 more, see the official notice) | Z-3031-2026 | 3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 3000545623, 3000550099, 3000550512 |
| healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001 | 200035, 200036, 200037, 200038, 200039, 200040, 30028 | Z-3032-2026 | – |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Healthmark Industries Co., Inc.
Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification