{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220725", "product_res_number": "Z-2713-2026", "event_date_initiated": "2026-05-18", "event_date_posted": "2026-07-09", "recall_status": "Open, Classified", "res_event_number": "99065", "product_code": "KQP", "k_numbers": [ "K100101" ], "product_description": "GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. \n\nUsed in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.", "code_info": "1. Product Code: 3303-001U. UDI-DI: 06438147321704. UDI-PI (PACKING LOT):\n(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). \n\n2. Product Code: 3303-0010. UDI-DI: 06438147311347. UDI-PI (PACKING LOT): (01)06438147311347(17)260531(10)763396 (1076339601); \n(01)06438147311347(17)260531(10)763396 (1076339602); \n(01)06438147311347(17)260531(10)764209 (1076420901); \n(01)06438147311347(17)260531(10)764209 (1076420902); \n(01)06438147311347(17)260731(10)765317 (1076531702); \n(01)06438147311347(17)260731(10)7653177 (1076531703); \n(01)06438147311347(17)261031(10)766378 (1076637801); \n(01)06438147311347(17)261031(10)766943 (1076694301); \n(01)06438147311347(17)261031(10)767323 (1076732301); \n(01)06438147311347(17)261130(10)767955 (1076795501); \n(01)06438147311347(17)261031(10)767956 (1076795601); \n(01)06438147311347(17)261130(10)769214 (1076921401); \n(01)06438147311347(17)261231(10)769967 (1076996701).", "firm_fei_number": "3002808498", "recalling_firm": "WALLAC OY", "address_1": "Mustionkatu 6 6 mustionkatu", "city": "Turku Varsinais-Suomi", "country": "Finland", "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.", "root_cause_description": "Nonconforming Material/Component", "action": "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: \n- 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).\n- Reagent cassettes should preferably be used within 12 hours (note: reduced on-board storage time).\n- 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).\n- 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.\n- Run calibration curve on each plate and evaluate the results against the plate-specific curve (note: do not use stored calibration curve).\nThese precautions are aimed at minimizing the fluctuation of the GALT activity results between assays/plates.\n\nConsignees 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.", "product_quantity": "3,274 units", "distribution_pattern": "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.", "openfda": { "k_number": [ "K894011", "K100101", "K101392", "K102643", "K990827", "K970277", "K993536" ], "registration_number": [ "8043909", "3050015" ], "fei_number": [ "3002808498", "3050015" ], "device_name": "Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1315", "device_class": "2" } } ] }