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Open, Classified

healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001

FDA Recall Z-3032-2026 · Posted 2026-08-26

Recall StatusOpen, Classified
Product CodeSDC
Date Initiated2026-07-29
Product Quantity53 units

Reason for Recall

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

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 who need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Customer Service via email at [email protected] 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."

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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