WALLAC recalls GSP Neonatal GALT Kit (product codes 3303-001U, 3303-0010) due to reduced on-board stability that may cause run-QC failures and delay patient result reporting.
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.
WALLAC is recalling its GSP Neonatal GALT Kit (product codes 3303-001U and 3303-0010) because the kit's stability may lead to failed quality control checks, which could delay reporting patient results. This is a laboratory diagnostic product used for fluorescent testing.
The kit's on-board stability is reduced, which can cause quality control failures during testing. These failures may delay the reporting of patient results, but the recall does not indicate a risk of injury or serious harm to users.
Healthcare facilities using the GSP Neonatal GALT Kit for fluorescent testing in laboratories are likely affected. Patients receiving results from these kits may experience delays in their test reporting.
Check for product codes 3303-001U or 3303-0010 on the kit. These are in vitro diagnostic products used in fluorescent testing for galactose-1-phosphate uridyl transferase analysis.
Look for product codes 3303-001U or 3303-0010 on the kit.
The recall is due to reduced on-board stability that may cause run-QC failures, potentially delaying patient result reporting.
The risk is that the kit may cause quality control failures, which could delay reporting patient results, but there is no mention of injury or serious harm.
Check for product codes 3303-001U or 3303-0010 on the kit, which are used in fluorescent testing for galactose-1-phosphate uridyl transferase analysis.
We’ve drafted a message you can send WALLAC to request your refund or repair — edit it as you like.
Subject: Recall Z-2713-2026 — WALLAC WALLAC Hello, I own a WALLAC that is covered by recall Z-2713-2026 from WALLAC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
