GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALAC

FDA device recall Z-2713-2026 · posted 2026-07-09 · Open, Classified

Recall details

Recalling firm

WALLAC OY

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

KQP

Quantity affected

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, Eg

Date initiated

2026-05-18

Date posted

2026-07-09

Location

Turku Varsinais-Suomi, Finland

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