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U.S. Department of Health and Human Services

Class 2 Device Recall Multichem

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 Class 2 Device Recall Multichemsee related information
Date Initiated by FirmOctober 17, 2025
Date PostedNovember 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0501-2026
Recall Event ID 97800
Product Classification Multi-analyte controls unassayed - Product Code OHQ
ProductMultichem 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.
Code Information Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026
Recalling Firm/
Manufacturer		 TECHNO-PATH MANUFACTURING LTD.
Fort Henry Business Park
Ballina Tipperary Ireland
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionLGC 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.
Quantity in Commerce76 units
DistributionUS distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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