Diagnostica Stago, Inc. recalls Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intende…

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

Diagnostica Stago notified consignees of the recall on about 12/15/2025 via email. Consignees were instructed to stop using Lot 271288 and dispose of all remaining product according to local regulations, and complete, sign, and return the attached Acknowledgement Form provided. Additionally, consignees were instructed that if they have distributed the affected lot to any other laboratory, please notify those recipients of this recall and ask them to complete and return an Acknowledgement Form.

• FDA enforcement recordOfficial FDA database entry for Z-1084-2026
• FDA 510(k) clearance · K003767The device's official FDA premarket clearance record
• FDA device classification · LCOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.7695The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Diagnostica Stago, 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.