FDA recall, , Moderate risk
GSP Neonatal GALT Kit
The GSP Neonatal GALT Kit may have a stability issue that can delay patient results.
Summary by Recall Canary from the FDA notice
What happened
WALLAC OY, located in Turku Varsinais-Suomi, Finland, recalled the GSP Neonatal GALT Kit, an in vitro diagnostic used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE, due to a 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. The company began the recall on May 18, 2026, and the FDA added it to its Enforcement Report on July 9, 2026.
The recall affects 3,274 units distributed nationwide in the United States, including states and territories such as AL, AR, AZ, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NJ, OR, PR, SC, TN, TX, VA, and WV, as well as countries including Austria, Belgium, Egypt, France, Germany, Hong Kong, Iraq, Italy, Netherlands, Oman, Philippines, Saudi Arabia, Singapore, Spain, Thailand, United Arab Emirates, and Vietnam. The product codes are 3303-001U and 3303-0010.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in Fluorescent Proc. (QUAL), Galactose-1-Phosphate Uridyl Transferase.
- UDI-DI
- 06438147321704
- 1076363801
- 1076408501
- 1076503301
- 1076523101
- 1076531601
- 1076642001
- 1076689401
- 1076763801
- 1076836101
- 1076870301
- 1076935501
- 1076954201
- 1076963201
- 1076967101
- 1076978201
- 1076987101
- 1076997501
- 1077007801
- 1077008601
- 1077035101
- 06438147311347
- 1076339601
- 1076339602
- 1076420901
- 1076420902
- 1076531702
- 1076531703
- 1076637801
- 1076694301
- 1076732301
- 1076795501
- 1076795601
- 1076921401
- 1076996701
- Lot code
- 260531
- 763638
- 763396
Recall details
- Company began the recall
- Sold in
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.
- Company
- WALLAC OYTurku Varsinais-Suomi, Finland
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99065
- Recall number
- Z-2713-2026
- Quantity recalled
- 3,274 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
