TECHNO-PATH MANUFACTURING LTD.: Medical Device Recall in 2025 - (Recall #: Z-0501-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 17, 2025

Date Posted: November 19, 2025

Recall Number: Z-0501-2026

Event ID: 97800

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.

Status: Ongoing

Product Quantity: 76 units

Code Information:

Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated