Ballina Tipperary, N/A, Ireland
TECHNO-PATH MANUFACTURING LTD. recalls
2 recalls recorded since 2018, most recently on 17 October 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 October 2025
- Reason
- 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.
- Distribution
- US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0501-2026, Z-0502-2026
- 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 Ig
- 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
Ongoing Class II Medical devices
- Recall started
- 25 August 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of Illinois.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0106-2024, Z-0104-2024, Z-0105-2024
- Multichem P, Part Code 08P90-10
- Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
- Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.