Recall Z-2713-2026— WALLAC OY

Name: FDA recall Z-2713-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-18

Class II · Ongoing

Class II FDA medical device recall by WALLAC OY, initiated 2026-05-18. It names one FDA 510(k) clearance: K100101. 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..

Recalling firm: WALLAC OY
Classification: Class II
Status: Ongoing
Initiated: 2026-05-18
Firm location: Turku Varsinais-Suomi, N/A, Finland

510(k) clearances named in this recall

1 on FDA's record

K100101 — GSP NEONATALGALT KIT, MODEL 3303-001UPerkinelmer, Inc.·cleared 2010-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.