Z-3032-2026 Class II Ongoing
FDA device recall Z-3032-2026 was initiated by Healthmark Industries Co., Inc. on July 29, 2026 and is designated Class II. Reason for recall: Test manufactured with an expired ingredient which may present as either a false negative or positive. The recall status is ongoing. Affected quantity: 53 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- July 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 units
Product Description
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Reason for Recall
Test manufactured with an expired ingredient which may present as either a false negative or positive.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Code Information
Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.