Healthmark ProChek-II Recall Issued for Expired Ingredient
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Healthmark Industries Co., Inc. is recalling 5,090 units of healthmark ProChek-II tests (models PT-313 and PT-201-12) due to an expired ingredient that may cause false negative or positive results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Test manufactured with an expired ingredient which may present as either a false negative or positive.", distributed worldwide distribution - us nationwide and the countries of canada, france, hong kong, south korea.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Healthmark Industries Co., Inc. initiated a voluntary recall of certain ProChek-II tests manufactured with an expired ingredient, which may present as either a false negative or positive result.
Which Products Are Affected
The recall covers 5,090 units of healthmark ProChek-II, Model Numbers PT-313 and PT-201-12 (H-PT-201-12). Affected lot/serial numbers for PT-313 include: 3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 3000545623, 3000550099, 3000550512, 313069 through 313108. Affected lot/serial numbers for H-PT-201-12 include: 7P0110, 7P0111, 7P0113, 7P0122. The recall number is Z-3031-2026. Distribution was nationwide in the United States and to Canada, France, Hong Kong, and South Korea.
What You Should Do
This is a Class II recall initiated voluntarily by the firm. Consumers with affected products should follow guidance from the recalling firm.
Why This Matters
The recall involves medical device tests distributed worldwide that may produce inaccurate results due to the use of an expired ingredient.
Source
FDA recall Z-3031-2026, event ID 99537. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,156 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.