Turku Varsinais-Suomi, N/A, Finland
WALLAC OY recalls
1 recall recorded since 2018, most recently on 18 May 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 May 2026
- Reason
- 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, Singapor
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2713-2026
- GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
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.