# FDA recall Z-0502-2026

> **TECHNO-PATH MANUFACTURING LTD.** · Class II · device recall initiated 2025-10-17.

## 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 anti-Treponema pallidum IgG.

## Reason for recall

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.

## Key facts

- **Recall number:** Z-0502-2026
- **Recalling firm:** TECHNO-PATH MANUFACTURING LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-17
- **Report date:** 2025-11-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0502-2026

## Citation

> AI Analytics. FDA recall Z-0502-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0502-2026. Source: US FDA. Licensed CC0.

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