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FDA · Medical devices ·

healthmark ProChek-II, Model Number PT-313, PT-201-12 recall

Healthmark Industries Co., Inc. recalled healthmark ProChek-II, Model Number PT-313, PT-201-12 on September 2, 2026 because of test manufactured with an expired ingredient which may present as either a false negative or positive. It was sold nationwide.

Why it was recalled

Test manufactured with an expired ingredient which may present as either a false negative or positive.

What's recalled

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

Quantity: 5090 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Healthmark Industries Co., Inc., Fraser, MI
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Status
Ongoing
Recall number
Z-3031-2026
Source
U.S. Food and Drug Administration

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