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Healthmark Industries Co., Inc.: healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001

Medical DevicesSource: FDA (device) · Date: 2026-09-02

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Healthmark Industries Co., Inc.
Product
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Reason / hazard
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Recall initiated
2026-07-29
Code info
Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.
Product quantity
53 units
Voluntary mandated
Voluntary: Firm initiated
City
Fraser
State
MI
Country
United States
Event id
99537
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