FDA Device recall Z-2713-2026
GSP Neonatal GALT Kit
- FDA Device
- Class II
- ongoing
- Published 2026-07-15
On 2026-07-15 the FDA classified a Class II recall of GSP Neonatal GALT Kit by Wallac Oy, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2713-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-18 |
| Published | 2026-07-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Wallac Oy |
| Distribution | US |
Product
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
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.
Identifiers
| code_info | 1. Product Code: 3303-001U. UDI-DI: 06438147321704. UDI-PI (PACKING LOT): (01)06438147321704(17)260531(10)763638 (10763…1. Product Code: 3303-001U. UDI-DI: 06438147321704. UDI-PI (PACKING LOT): (01)06438147321704(17)260531(10)763638 (1076363801); (01)06438147321704(17)260531(10)764085 (1076408501); (01)06438147321704(17)260531(10)765033 (1076503301); (01)06438147321704(17)260731(10)765231 (1076523101); (01)06438147321704(17)260731(10)765316 (1076531601); (01)06438147321704(17)261031(10)766420 (1076642001); (01)06438147321704(17)261031(10)766894 (1076689401); (01)06438147321704(17)261130(10)767873 (1076763801); (01)06438147321704(17)261130(10)768361 (1076836101); (01)06438147321704(17)261130(10)768703 (1076870301); (01)06438147321704(17)270228(10)769355 (1076935501); (01)06438147321704(17)270228(10)769542 (1076954201); (01)06438147321704(17)270228(10)769632 (1076963201); (01)06438147321704(17)270228(10)769671 (1076967101); (01)06438147321704(17)270228(10)769782 (1076978201); (01)06438147321704(17)270228(10)769871 (1076987101); (01)06438147321704(17)270228(10)769975 (1076997501); (01)06438147321704(17)270 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2713-2026%22
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