GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010.… recallZ-2713-2026 · Wallac Oy · initiated May 18, 2026

Why it was recalled

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 root cause category: Nonconforming Material/Component

What the company 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.

Recall details

Recall number

Z-2713-2026

Status

Open, Classified

Initiated by the company

May 18, 2026

Posted by the FDA

Jul 9, 2026

Recalling firm

Wallac Oy

Quantity

3,274 units

Product code

KQP

FDA submissions

K100101

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.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• GSP Neonatal GALT kit 3303-001U

  Wallac Oy · Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
  1 recall0 reports