FDAFDA recall Z-2713-2026 · Jul 15, 2026

WALLAC OY: GSP Neonatal GALT Kit recall

Recall found

Product

GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.

Reason for recall

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 1. Product Code: 3303-001U. UDI-DI: 06438147321704. UDI-PI (PACKING LOT): (01)06438147321704(17)260531(10)763638 (1076363801); (01)06438147321704(17)260531(10)764085 (1076408501); (01)06438147321704(17)260531(10)765033 (1076503301); (01)06438147321704(17)260731(10)765231 (1076523101); (01)06438147321704(17)260731(10)765316 (1076531601); (01)06438147321704(17)261031(10)766420 (1076642001); (01)06438147321704(17)261031(10)766894 (1076689401); (01)06438147321704(17)261130(10)767873 (1076763801); (01)06438147321704(17)261130(10)768361 (1076836101); (01)06438147321704(17)261130(10)768703 (1076870301); (01)06438147321704(17)270228(10)769355 (1076935501); (01)06438147321704(17)270228(10)769542 (1076954201); (01)06438147321704(17)270228(10)769632 (1076963201); (01)06438147321704(17)270228(10)769671 (1076967101); (01)06438147321704(17)270228(10)769782 (1076978201); (01)06438147321704(17)270228(10)769871 (1076987101); (01)06438147321704(17)270228(10)769975 (1076997501); (01)06438147321704(17)270228(10)770078 (1077007801); (01)06438147321704(17)270228(10)770086 (1077008601); (01)06438147321704(17)270228(10)770351 (1077035101). 2. Product Code: 3303-0010. UDI-DI: 06438147311347. UDI-PI (PACKING LOT): (01)06438147311347(17)260531(10)763396 (1076339601); (01)06438147311347(17)260531(10)763396 (1076339602); (01)06438147311347(17)260531(10)764209 (1076420901); (01)06438147311347(17)260531(10)764209 (1076420902); (01)06438147311347(17)260731(10)765317 (1076531702); (01)06438147311347(17)260731(10)7653177 (1076531703); (01)06438147311347(17)261031(10)766378 (1076637801); (01)06438147311347(17)261031(10)766943 (1076694301); (01)06438147311347(17)261031(10)767323 (1076732301); (01)06438147311347(17)261130(10)767955 (1076795501); (01)06438147311347(17)261031(10)767956 (1076795601); (01)06438147311347(17)261130(10)769214 (1076921401); (01)06438147311347(17)261231(10)769967 (1076996701).
Quantity: 3,274 units
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, Singapore, Spain, Thailand, United Arab Emirates, Vietnam.
Recalling firm: WALLAC OY, Turku Varsinais-Suomi, N/A
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-05-18

Source: openFDA enforcement record Z-2713-2026 · search recall number Z-2713-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.