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

Class II
Recalling firm
WALLAC OY
Reason for recall
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.
Distribution pattern
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.
State
N/A
Status
Ongoing
Recall number
Z-2713-2026
Recall initiated
May 18, 2026
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