Healthmark ProChek-W and ProChek-SQ Protein Test Recall Over Expired Ingredient

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Healthmark Industries Co., Inc. is recalling 53 units of healthmark ProChek protein tests 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 10, 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 protein tests manufactured with an expired ingredient which may present as either a false negative or positive.

Which Products Are Affected

The recall affects healthmark ProChek-W Protein Test for Robotic Arms and ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001. A total of 53 units distributed worldwide, including US Nationwide and the countries of Canada, France, Hong Kong, and South Korea, are affected. Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028. The recall number is Z-3032-2026.

What You Should Do

The recall was initiated voluntarily by the firm via email, fax, letter, press release, telephone, and visit.

Why This Matters

The affected tests may produce inaccurate results due to the expired ingredient.

Source

FDA recall number Z-3032-2026, Class II, event ID 99537.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Healthmark Industries Co., Inc. is recalling 53 units of healthmark ProChek protein tests due to an expired ingredient that may cause false negative or positive results.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "Test manufactured with an expired ingredient which may present as either a false negative or positive." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.