Recall Z-3031-2026
Healthmark Industries Co., Inc. · initiated July 29, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
healthmark ProChek-II, Model Number PT-313, PT-201-12
Codes / lots: PT-313 - Serial/Lot Numbers: 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, 313101, 313102, 313106, 313107; H-PT-201-12 - Serial/Lot Numbers: 7P0110, 7P0111, 7P0113, 7P0122.
Reason for recall
Test manufactured with an expired ingredient which may present as either a false negative or positive.
FDA-determined cause: Under Investigation by firm
Action taken
GETINGE issued an URGENT MEDICAL DEVICE RECALL/REMOVAL to its consignees on 7/29/2026 via email and telephone. The notice explained the issue, risks to health, and requested the following: "Customer Actions Our records indicate that your facility has received one or more of the affected devices that are affected by this notice. As a result, Healthmark requests that your facility takes the following actions: 1. Ensure all affected product in your facility s inventory is no longer in use and has been properly quarantined. 2. Please ensure this message is forwarded to any individuals who need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Customer Service via email at HMCS@hmark.com or 800-521-6224 to return your unused affected product or if you have any questions. 4. Please fill out the Customer Response Form using the link or QR code provided below. Getinge has partnered with IQVIA MedTech to coordinate the recall response process."
Details
- Recall number
- Z-3031-2026
- Initiated
- July 29, 2026
- Posted by FDA
- August 26, 2026
- Product code
- SDC – Qualitative Cleaning Process Protein Indicator
- Quantity
- 5090 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
- Recalling firm
- Healthmark Industries Co., Inc., Fraser, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3032-2026 Class II | healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein…Test manufactured with an expired ingredient which may present as either a false negative or positive. | 07/29/2026Open, Classified |