Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to mon

FDA device recall Z-0502-2026 · posted 2025-11-14 · Open, Classified

Recall details

Recalling firm

TECHNO-PATH MANUFACTURING LTD.

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

OHQ

Quantity affected

51 units

Distribution

US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.

Date initiated

2025-10-17

Date posted

2025-11-14

Location

Ballina Tipperary, Ireland