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U.S. Department of Health and Human Services

Class 2 Device Recall GSP Neonatal GALT Kit

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 Class 2 Device Recall GSP Neonatal GALT Kitsee related information
Date Initiated by FirmMay 18, 2026
Date PostedJuly 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2713-2026
Recall Event ID 99065
510(K)NumberK100101 
Product Classification Fluorescent proc. (qual.), galactose-1-phosphate uridyl transferase - Product Code KQP
ProductGSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
Code Information 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).
FEI Number 3002808498
Recalling Firm/
Manufacturer		 WALLAC OY
Mustionkatu 6
Turku Varsinais-Suomi Finland
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionWallac 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.
Quantity in Commerce3,274 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KQP
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