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MEDICAL DEVICE RECALLMODERATE
ZYMUTEST HIA IgG ELISA Kit
ZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.
What to do
Stop using ZYMUTEST HIA IgG ELISA kit lot FD1265 immediately. Contact Aniara Diagnostica LLC for instructions on kit return or replacement and guidance on any affected test results.
Why it was recalled
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
How to identify it
UPC 03663537018763
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Where it was sold
Distributed in US.
Official source
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Editorial summary by Recall Canary · last updated 2026-05-13 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification