The Recall Desk
HighFDA (Devices)·Z-0502-2026·Announced 2025-11-19

Second control serum lot recalled over negative HBsAg analyte recovery

Techno-Path is recalling 51 units of Multichem ID-B positive control serum from a second lot because of potential negative recovery of the HBsAg analyte on the Alinity i platform.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: a quality control that fails to recover its analyte can mask a testing problem, and no injuries are reported.

Plain-English summary

Multichem ID-B, model SR103B, is being recalled. The product is intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for determinations including anti-HIV-1 IgG, anti-HBc IgG and anti-HTLV-I IgG.

The firm identifies the potential of negative recovery of the HBsAg analyte across two lots of Multichem ID-B Positive Control when tested on the Alinity i platform.

This record covers 51 units from lot SB161024P, carrying UDI 05391523442312. The product was distributed in California, Colorado, Connecticut, Florida, Hawaii, Illinois, Louisiana, Michigan, Minnesota, Nevada, New York, Oregon, South Carolina, Tennessee, Texas, Wisconsin and Wyoming. The FDA has classified the action as Class II.

A positive control that reads negative undermines the quality check on hepatitis B surface antigen testing. Laboratories holding the affected lot should follow the firm's instructions.

The recalled product

Product
Multichem ID-B. Model 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 ant
Manufacturer
TECHNO-PATH MANUFACTURING LTD.
Category
Medical Device — Quality control material
Hazard
Affected units
51

Distribution

Distributed in 17 states:

Part of a larger recall action

This product is one of 2 recalled by TECHNO-PATH MANUFACTURING LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · TECHNO-PATH MANUFACTURING LTD.

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Same hazard · control failure

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