Reported Jul 15, 2026 · Ongoing · Updated Sep 16, 2026
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL),…
Wallac Oy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: WALLAC OY · Mustionkatu 6 · Turku Varsinais-Suomi
Is this the product you have?
- GSP Neonatal GALT Kit
- Product Codes3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE
- Lot codes and dates
32 of 32 products
Products covered by this recall Model / number Barcodes Product as published 3303-001U.0643814732170406438147321704UDI-DI: 06438147321704. UDI-PI (PACKING LOT): (01)06438147321704(17)260531(10)763638 (1076363801) — 06438147321704(01)06438147321704(17)260531(10)764085 (1076408501) — 06438147321704(01)06438147321704(17)260531(10)765033 (1076503301) — 06438147321704(01)06438147321704(17)260731(10)765231 (1076523101) — 06438147321704(01)06438147321704(17)260731(10)765316 (1076531601) — 06438147321704(01)06438147321704(17)261031(10)766420 (1076642001) — 06438147321704(01)06438147321704(17)261031(10)766894 (1076689401) — 06438147321704(01)06438147321704(17)261130(10)767873 (1076763801) — 06438147321704(01)06438147321704(17)261130(10)768361 (1076836101) — 06438147321704(01)06438147321704(17)261130(10)768703 (1076870301) — 06438147321704(01)06438147321704(17)270228(10)769355 (1076935501) — 06438147321704(01)06438147321704(17)270228(10)769542 (1076954201) — 06438147321704(01)06438147321704(17)270228(10)769632 (1076963201) — 06438147321704(01)06438147321704(17)270228(10)769671 (1076967101) — 06438147321704(01)06438147321704(17)270228(10)769782 (1076978201) — 06438147321704(01)06438147321704(17)270228(10)769871 (1076987101) — 06438147321704(01)06438147321704(17)270228(10)769975 (1076997501) — 06438147321704(01)06438147321704(17)270228(10)770078 (1077007801) — 06438147321704(01)06438147321704(17)270228(10)770086 (1077008601) 3303-0010.064381473217040643814731134706438147311347(01)06438147321704(17)270228(10)770351 (1077035101). 2. UDI-DI: 06438147311347. UDI-PI (PACKING LOT): (01)06438147311347(17)260531(10)763396 (1076339601) - Amount recalled
- 3,274 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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