WALLAC OY 2026-07-15 Health serious FDA
Health · FDA · Recall #FDA-Z-2713-2026
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. … Recall
Issued July 15, 2026 · WALLAC OY
In July 2026, WALLAC OY recalled the GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. …, a serious health recall reported by the FDA.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact WALLAC OY to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- WALLAC OY
- Category
- Health
- Recall date
- July 15, 2026
- Units affected
- Not reported
- Sold at
- 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,
- Recall number
- FDA-Z-2713-2026
- Made in
- Finland
- Issuing agency
- FDA
In context
- WALLAC OY has 1 recall in our database.
- We're tracking 3,673 Health recalls in our database.
- This is the 453rd Health recall we've logged in 2026.