Aniara Diagnostica Recalls ZYMUTEST HIA IgG ELISA Kits
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Aniara Diagnostica LLC is recalling 359 units of ZYMUTEST HIA IgG in vitro diagnostic ELISA kits due to an outdated flyer with incorrect positive control values.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 2, 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
Aniara Diagnostica LLC initiated a voluntary recall of ZYMUTEST HIA IgG kits because lot FD1265 was packaged with an outdated flyer containing incorrect values for the positive control.
Which Products Are Affected
The recall affects ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A, UDI-DI 03663537018763, Lot Number FD1265. A total of 359 units were distributed nationwide in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI. The recall number is Z-2171-2026.
What You Should Do
Consumers should follow guidance from the recalling firm regarding the affected kits.
Why This Matters
The recall involves in vitro diagnostic kits distributed across multiple U.S. states.
Source
FDA recall Z-2171-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (772 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.