WALLAC recalls GSP Neonatal GALT Kit (product codes 3303-001U, 3303-0010) due to reduced on-board stability that may cause run-QC failures and delay patient result reporting.
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.
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📍Recalling firmWALLAC OYMustionkatu 6 · Turku Varsinais-Suomi, Finland
✎ GovInfoNow plain-language explainer
WALLAC is recalling its GSP Neonatal GALT Kit (product codes 3303-001U and 3303-0010) because the kit's stability may lead to failed quality control checks, which could delay reporting patient results. This is a laboratory diagnostic product used for fluorescent testing. Read more at govinfonow.com/recall/49154-wallac-gsp-neonatal-galt-kit-recall-reduced-stability-may-delay.
“WALLAC GSP Neonatal GALT Kit Recall: Reduced Stability May Delay Patient Results.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49154-wallac-gsp-neonatal-galt-kit-recall-reduced-stability-may-delay. Based on FDA recall #Z-2713-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2713-2026%22&limit=1).
WALLAC OY recalled GSP Neonatal GALT Kits due to reduced on-board stability that may delay patient result reporting, the FDA said on May 18, 2026. The recall affects 3,274 units distributed worldwide.
How to tell if you have it
Brand: WALLAC
Product: GSP Neonatal GALT Kit
Product Codes: 3303-001U, 3303-0010
UPCs: 06438147311347, 06438147321704
The hazard
The recall involves a reduction in the on-board stability of the GSP GALT assay. This issue may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
Context
GovInfoNow's records show other recent recalls of similar products include Medline GYN Laparoscopy Kits (2026-02-25), Windstone Aligned Medical AMS16835 Fluids Kit (2026-04-27), and Medline TRACH TUBE KIT (2026-07-10).
How to tell if you have this one
Check for product codes 3303-001U or 3303-0010 on the kit. These are in vitro diagnostic products used in fluorescent testing for galactose-1-phosphate uridyl transferase analysis.
Brand
WALLAC
Product
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL)
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Code
Look for product codes 3303-001U or 3303-0010 on the kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, New Jersey, Oregon, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, West Virginia.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2713-2026 (May 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2713-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.