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WALLAC OY Recalls

1 recall on record · July 15, 2026 to July 15, 2026 · Medical Devices

July 15, 2026Medical DevicesFDA

WALLAC OY recalls GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL),

Hazard: 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.