CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

healthmark ProChek-W Protein Test for Robotic Arms recalled

Healthmark Industries is recalling healthmark ProChek-W Protein Test for Robotic Arms, distributed nationwide in the US. The recall was initiated on 29 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.

Quantity recalled53 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3032-2026
FDA event ID: 99537
Recalling firm: Healthmark Industries, Fraser, MI
Classification: Class II
Status: Ongoing
Recall initiated: 29 Jul 2026
FDA classified: 26 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Jul 2026	Recall initiated by company
26 Aug 2026	Classified by FDA	+28 days
2 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99537

This product is part of a recall event; the main page for the event is healthmark ProChek-II recalled by Healthmark Industries Co.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026	CLASS II	healthmark ProChek-II recalled by Healthmark Industries Co	Healthmark Industries	Other	Nationwide

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