Recall Z-3032-2026 ยท SDC Qualitative Cleaning Process Protein Indicator
Healthmark Industries Co., Inc.
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
| Date | Aug 26, 2026 (initiated Jul 29, 2026) |
| Status | Open, Classified |
| Reason | Test manufactured with an expired ingredient which may present as either a false negative or positive. |
| Root cause | Under Investigation by firm |
| Action | 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 w |
| Quantity | 53 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.