GSP Neonatal GALT Kit
The GSP Neonatal GALT Kit is recalled due to reduced on-board stability, which may cause test failures and delays in patient results.
Healthcare providers should discontinue use of the affected kits and contact the manufacturer for further instructions regarding replacement or testing protocols.
Recall at a glance
- Quantity recalled
- 3,274 units
Why it was recalled
The GSP Neonatal GALT Kit is being recalled due to a reduction in on-board stability for the assay. This issue may cause quality control failures during testing, potentially leading to delays in reporting patient results.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
- Lot code
- 260531, 763638, 1076363801, 763396, 1076339601
- UDI-DI
- 06438147321704, 06438147321704, 1076363801, 06438147321704, 1076408501, 06438147321704, 1076503301, 06438147321704, 1076523101, 06438147321704, 1076531601, 06438147321704, 1076642001, 06438147321704, 1076689401, 06438147321704, 1076763801, 06438147321704, 1076836101, 06438147321704
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-07-10 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification