Multichem ID-B (Techno-Path) – HBsAg Recovery Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
Brand
TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026
TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland is recalling Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY
Page updated: Jan 10, 2026