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RecallWatchMedical Device Safety
Class IIOngoingZ-2713-2026

WALLAC OY recalls GSP Neonatal GALT Kit. Product Codes: 3303-001U

WALLAC OYTurku Varsinais-Suomi, FinlandReported Jul 15, 2026 · 7 days ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

UDI
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…Show all
): (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
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)764…Show all
): (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)

What the firm is doing

Wallac Oy, a Revvity company, notified consignees on about 05/18/2026 via emailed "URGENT: MEDCIAL DEVICE RECALL" letter. Consignees were instructed to inspect inventory for the affected lots and dispose of affected lots according to local requirements. If consignees do not have another GSP Neonatal GALT kit lot at hand, the newborn screening for classical galactosemia may be continued, with following instructions: - Reconstitute GALT Substrate Reagent by adding 2.8 mL of GALT Assay Buffer and invert gently for 20-30 minutes (note: slightly extended dissolving time). - Reagent cassettes should preferably be used within 12 hours (note: reduced on-board storage time). - Load reagent cassette to GSP without additional delay after reconstitution of Substrate Reagent (one reagent cassette is sufficient for measurement of four full plates (384 wells). - If possible, prioritize GALT plates first if multiple analytes/kits are run within the same instrument. Avoid exceeding the on-board storage time of 12 hours for the reagent cassette. - Run calibration curve on each plate and evaluate the results against the plate-specific curve (note: do not use stored calibration curve). These precautions are aimed at minimizing the fluctuation of the GALT activity results between assays/plates. Consignees were also requested to complete and return the response form provided. Revvity will replace the quantity of excessive kit usage and the affected GSP Neonatal GALT kits disposed from inventory upon receipt of the response form.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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