The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2713-2026·Announced 2026-07-15

GSP Neonatal GALT Kit in vitro diagnostic test equipment

WALLAC OY is recalling GSP Neonatal GALT Kit units due to reduced on-board stability that may increase run-QC failures and delay patient test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The hazard is operational (test failure/delayed results) rather than direct patient harm, and the source text explicitly describes a risk of delays rather than adverse health consequences. No illnesses, injuries, or hospitalizations are reported.

Plain-English summary

WALLAC OY is recalling GSP Neonatal GALT Kit units with product codes 3303-001U and 3303-0010. The kit is an in vitro diagnostic device used in fluorescent procedures to measure galactose-1-phosphate uridyl transferase levels, typically for neonatal screening.

The recall is due to a reduction in the on-board stability of the GSP GALT assay. This reduction may increase the likelihood of run-QC (quality control) failures. Run-QC failures can result in delays in reporting patient test results.

The recalled kits have been distributed nationwide across multiple U.S. states and territories including Alabama, Arkansas, Arizona, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Jersey, Oregon, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, and West Virginia. International distribution includes Austria, Belgium, Egypt, France, Germany, Hong Kong, Iraq, Italy, Netherlands, Oman, Philippines, Saudi Arabia, Singapore, Spain, Thailand, United Arab Emirates, and Vietnam. A total of 3,274 units are affected.

Healthcare facilities and laboratories using affected lot numbers should contact WALLAC OY for guidance on remediation or product replacement.

The recalled product

Product
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
Manufacturer
WALLAC OY
Category
Medical Device — In vitro diagnostic
Hazard
Affected units
3,274

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (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)06438147311347(17)260531(10)763396 (1076339602)
  • (01)06438147311347(17)260531(10)764209 (1076420901)

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

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