GSP Neonatal GALT Kit — Class II medical device recall Z-2713-2026
Ongoing recall by WALLAC OY, reported 2026-07-15, distributed nationwide. Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures
| Recall number | Z-2713-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | WALLAC OY, Turku Varsinais-Suomi, N/A, Finland |
| Recall initiated | 2026-05-18 |
| Classified | 2026-07-09 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, DE, EG, ES, FR, HK, IQ, IT, NL, OM, PH, SA, SG, TH, VN |
| Quantity | 3,274 units |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 06438147311347, 06438147321704 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2713-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.