TECHNO-PATH MANUFACTURING LTD. recalls Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positi…

Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.

LGC Clinical Diagnostics notified consignees on about 10/17/2025 via letter that Techno-path Manufacturing Ltd was recalling specific Multichem ID-B products. Consignee were informed that the Instructions for Use (IFU) for Multichem ID-B SR103B, Lots SB140524P and SB161024P have been updated to remove the representative reactivity for the analyte HBsAg; therefore, no representative reactivity result will be provided for HBsAg in these lots. Consignees were instructed to discard all previous versions of the IFU for affected lots, share the information with all applicable laboratory staff or customers if further distributed, retain the notification as part of the laboratory Quality System documentation, and complete and return the provided response form. Techno-path Manufacturing Ltd. is investigating this issue and will implement a correction for all future lots of Multichem ID-B Positive Control SR103B that will be released.

• FDA enforcement recordOfficial FDA database entry for Z-0501-2026
• FDA device classification · OHQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find TECHNO-PATH MANUFACTURING LTD.Search for the manufacturer's official notice
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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.