GSP Neonatal GALT Kit Recall Issued by Wallac Oy
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Wallac Oy is recalling 3,274 units of the GSP Neonatal GALT Kit due to reduced on-board stability that may cause QC failures and delay patient results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Wallac Oy initiated a voluntary recall of the GSP Neonatal GALT Kit after identifying a reduction in the on-board stability of the GSP GALT assay. This issue may increase the likelihood of run-QC failures and delay the reporting of patient results.
Which Products Are Affected
The recall covers the GSP Neonatal GALT Kit with product codes 3303-001U and 3303-0010. A total of 3,274 units are affected. The products are in vitro diagnostic devices used in fluorescent procedures for qualitative detection of galactose-1-phosphate uridyl transferase. Distribution includes US nationwide in the states and territories of AL, AR, AZ, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NJ, OR, PR, SC, TN, TX, VA, WV, as well as multiple other countries worldwide. The FDA recall number is Z-2713-2026.
What You Should Do
Consumers and laboratories should follow guidance from the recalling firm regarding affected lots and any necessary actions to address potential delays in patient results.
Why This Matters
The stability reduction may lead to QC failures and delays in reporting patient results for this in vitro diagnostic assay.
Source
FDA recall Z-2713-2026 (Class II, ongoing).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,206 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.