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Techno-path Manufacturing Ltd.

Ireland IE-MF-000001822 Last updated 23 Oct 2026

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Devices
27
Registries
EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls
55 ongoing

Catalogue27

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • V13 103852 0016 Issued

    Quality management system EU IVDR

    Issued
    24 Jul 2026
    Expires
    4 Aug 2027

Related companies

Notified bodies

FDA recalls5

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2025

    • 17 Oct 2025 Z-0501-2026 Class II Ongoing 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.
    • 17 Oct 2025 Z-0502-2026 Class II Ongoing 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.

  • 2023

    • 25 Aug 2023 Z-0104-2024 Class II Ongoing 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 receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.
    • 25 Aug 2023 Z-0105-2024 Class II Ongoing 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 receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.
    • 25 Aug 2023 Z-0106-2024 Class II Ongoing 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 receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.

About

Technopath Clinical Diagnostics manufacture Multichem third-party quality controls and IAMQC informatic software solutions for use in clinical laboratories world wide.

From the manufacturer's own website, in their original language. Source

What Techno-path Manufacturing Ltd. makes

Techno-path Manufacturing Ltd. produces in vitro diagnostic devices including reagents, calibrators, and controls such as Lp-PLA Reagent, Lp-PLA2 Calibrator, Multichem AMH, and Multichem ID-G, as well as systems like MULTICHEM IA AND IA PLUS, MULTICHEM S PLUS / S PLUS (ASSAYED), and MULTICHEM WBT.

The company's portfolio includes devices classified as Class I, Class II, Class B, and IVD General, listed in regulatory registries eudamed and fda_510k. Techno-path Manufacturing Ltd. is based in Ireland.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Techno-path Manufacturing Ltd. produce?

Techno-path Manufacturing Ltd. produces in vitro diagnostic devices including reagents, calibrators, and controls such as Lp-PLA Reagent, Lp-PLA2 Calibrator, Multichem AMH, and Multichem ID-G, as well as systems like MULTICHEM IA AND IA PLUS, MULTICHEM S PLUS / S PLUS (ASSAYED), and MULTICHEM WBT.

Where is Techno-path Manufacturing Ltd. based?

Techno-path Manufacturing Ltd. is based in Ireland, as indicated by the country code IE in their device data.

Which regulatory registries list Techno-path Manufacturing Ltd.'s devices?

Techno-path Manufacturing Ltd.'s devices are listed in the eudamed and fda_510k regulatory registries, as specified in their device data.

How are Techno-path Manufacturing Ltd.'s devices classified?

Techno-path Manufacturing Ltd.'s devices are classified as Class I, Class II, Class B, and IVD General, which indicates varying levels of regulatory control based on the intended use and potential risks of each device.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Ireland
Address
Fort Henry Business Park, Co. Tipperary, Ireland
Phone
+353 61 525700
PRRC contact
Linda Power
EUDAMED SRN
IE-MF-000001822
FDA FEI number
3008156187