WALLAC OY — Class II: GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used
Wallac Oy has initiated a Class II recall for the GSP Neonatal GALT Kit due to a reduction in on-board stability for the assay. This stability issue may lead to an increased frequency of Quality Control (QC) run failures and delays in reporting patient results.
This affects clinical laboratories utilizing fluorescent procedures for Galactose-1-phosphate uridyl transferase testing, specifically those using Wallac Oy GSP Neonatal GALT Kits (Product Codes 3303-001U and 3303-0010).
A reduction in on-board stability suggests the reagents may not perform as validated over the expected duration when loaded on the instrument. From a regulatory perspective, this implies a potential deviation from the product's cleared performance specifications, necessitating corrective action to ensure diagnostic reliability and prevent clinical workflow disruptions caused by repeat testing.
Quality and laboratory teams should verify current inventory against the specified product codes (3303-001U, 3303-0010) and evaluate internal stability protocols. Regulatory teams may need to review technical documentation regarding on-board stability claims and prepare for potential reporting delays in clinical settings.
Class II. 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.. Product: GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.. Firm: WALLAC OY (Turku Varsinais-Suomi N/A Finland). Status: Ongoing.
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