# FDA recall Z-0106-2024

> **TECHNO-PATH MANUFACTURING LTD.** · Class II · device recall initiated 2023-08-25.

## Product

Multichem P, Part Code 08P90-10

## Reason for recall

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.

## Key facts

- **Recall number:** Z-0106-2024
- **Recalling firm:** TECHNO-PATH MANUFACTURING LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-25
- **Report date:** 2023-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ballina Tipperary, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0106-2024

## Citation

> AI Analytics. FDA recall Z-0106-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0106-2024. Source: US FDA. Licensed CC0.

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