# FDA recall Z-2713-2026

> **WALLAC OY** · Class II · device recall initiated 2026-05-18.

## Product

GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic.      Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.

## Reason for recall

Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

## Distribution

Worldwide - US Nationwide distribution in the states and territories of AL, AR, AZ, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NJ, OR, PR, SC, TN, TX, VA, WV and the countries of Austria, Belgium, Egypt, France, Germany, Hong Kong, Iraq, Italy, Netherlands, Oman, Philippines, Saudi Arabia, Singapore, Spain, Thailand, United Arab Emirates, Vietnam.

## Key facts

- **Recall number:** Z-2713-2026
- **Recalling firm:** WALLAC OY
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-18
- **Report date:** 2026-07-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Turku Varsinais-Suomi, N/A, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2713-2026

## Citation

> MORVS. FDA recall Z-2713-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2713-2026. Source: US FDA. Licensed CC0.

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