The Recall Desk

FDA (Devices) recall action 97800

TECHNO-PATH MANUFACTURING LTD. recalled 2 products on 2025-11-19

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-11-19
Critical
0
Units
127

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    17 states
  • HighFDA (Devices)··2025-11-19

    Positive control serum recalled over negative recovery of the HBsAg analyte

    Techno-Path is recalling 76 units of Multichem ID-B positive control serum because of potential negative recovery of the HBsAg analyte on the Alinity i platform.

    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
    Category
    Distribution
    17 states