FDA-Device2026-05-20Class IIMISBRANDING
Aniara Diagnostica ZYMUTEST HIA IgG ELISA kit recalled for incorrect control values
LABEL MIX UPNationwide distribution
Aniara ZYMUTEST HIA IgG kit recalled for incorrect control values
Lot FD1265 of the ZYMUTEST HIA IgG diagnostic kit was shipped with an outdated instruction flyer that contained incorrect values for the positive control. This could lead to misinterpretation of test results if users rely on the wrong reference values.
- If you have lot FD1265, do not use the outdated flyer included in the package.
- Contact Aniara Diagnostica LLC for corrected control values.
- Review test results from this lot against the correct positive control values before reporting them.
Hazard
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Sold states
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Affected count
359 units
Manufactured in
7768 Service Center Dr, West Chester, OH, United States
Products
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2171-2026Don't want to check this manually?
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