Urgent Field Safety Notice For Gsp Neonatal Galt Kit By Wallac Oy

Recall Summary Wallac Oy is issuing an urgent field safety notice for the GSP Neonatal GALT kit, a Class I medical device used for newborn screening. The notice was distributed in Germany and the EU in June 2026, though the specific reason for the recall is not clearly detailed in the available information. This notice affects users of this diagnostic testing kit in those regions.

Recalling firm

Urgent Field Safety Notice for GSP Neonatal GALT kit by Wallac Oy , Download_VeroeffentlichtAm_EN 2026.06.05 PDF, 503KB,

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for GSP Neonatal GALT kit by Wallac Oy 2026

Reason

assessment Field corrective actions Urgent Field Safety Notice for GSP Neonatal GALT kit by Wallac Oy 2026

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-06-05

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/e7eed954-3e9d-430f-aa01-70cd375767b5