RegWardenFDA facility compliance records
Company

Techno-path Manufacturing Ltd.

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2023: 1 recalls; 2025: 1 recalls201720182019202020212022120232024120252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-10-17
    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.
  • Class IIOngoing2023-08-25
    Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receivi…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Techno-path Manufacturing Ltd. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10030933-techno-path-manufacturing-ltd/

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