FDAClass IISeptember 2, 2026

healthmark ProChek-II recall

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

Why was healthmark ProChek-II recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
healthmark ProChek-II, Model Number PT-313, PT-201-12
Recalling firm
Healthmark Industries Co., Inc.
Quantity
5090 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Recall date
September 2, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls