OVERLOOKED

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Class IIOngoing

Healthmark Industries Co., Inc. recalls 2 products

Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Healthmark Industries Co., Inc.
Reason
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99537…

Products (2)

  1. healthmark ProChek-II, Model Number PT-313, PT-201-12

    Codes/lots: 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.Quantity: 5090 unitsRecall no. Z-3031-2026Class II

  2. healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001

    Codes/lots: Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.Quantity: 53 unitsRecall no. Z-3032-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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