Healthmark Industries Co., Inc. recalls healthmark ProChek-II

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

healthmark ProChek-II, Model Number PT-313, PT-201-12

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."

• FDA enforcement recordOfficial FDA database entry for Z-3031-2026
• FDA device classification · SDCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.6930The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Healthmark Industries Co., Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.