FDA recall, , Moderate risk
Healthmark ProChek Protein Tests
The ProChek tests were made with an expired ingredient, which may cause false results.
Summary by Recall Canary from the FDA notice
What happened
Healthmark Industries Co., Inc., of Fraser, Michigan, recalled its Healthmark ProChek-II and Healthmark ProChek-W Protein Test for Robotic Arms because the tests were manufactured with an expired ingredient, which may present as either a false negative or positive. The recall began July 29, 2026, and was added to the FDA's Enforcement Report on August 26, 2026. The products were distributed worldwide, including the US Nationwide and the countries of Canada, France, Hong Kong, and South Korea.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code and UDI-DI are listed under that product.
Incomplete list: 47 of 55 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
- Lot code
- 200035
- 200036
- 200037
- 200038
- 200039
- 200040
- 30028
healthmark ProChek-II, Model Number PT-313, PT-201-12
- UDI-DI
- 3000535312
- 3000535333
- 3000536416
- 3000536423
- 3000537810
- 3000537822
- 3000542453
- 3000545623
- 3000550099
- 3000550512
- Lot code
- 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
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
- Company
- Healthmark Industries Co., Inc.Fraser, Michigan
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99537
- Recall numbers
- Z-3031-2026 to Z-3032-2026
All recalls from Healthmark Industries Co., Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
