Recall Z-2713-2026 ยท KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
WALLAC OY
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
| Date | Jul 9, 2026 (initiated May 18, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Wallac Oy, a Revvity company, notified consignees on about 05/18/2026 via emailed "URGENT: MEDCIAL DEVICE RECALL" letter. Consignees were instructed to inspect inventory for the affected lots and dispose of affected lots according to local requirements. If consignees do not have another GSP Neonatal GALT kit lot at hand, the newborn screening for classical galactosemia may be continued, with following instructions: - Reconstitute GALT Substrate Reagent by adding 2.8 mL of GALT Assay Buffer and invert gently for 20-30 minutes (note: slightly extended dissolving time). - Reagent cassettes shoul |
| Quantity | 3,274 units |
| 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, Italy, Netherlands, Oman, Philippines, Saudi Arabia, Singapor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U Perkinelmer, Inc., Jun 11, 2010 |