Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Take action
Contact the company
📍Recalling firmAniara Diagnostica LLC7768 Service Center Dr · West Chester, OH 45069-2442
“Aniara Diagnostica ZYMUTEST HIA IgG Kit Recall: Incorrect Positive Control Values.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49572-aniara-diagnostica-zymutest-hia-igg-kit-recall-incorrect-positive-control. Based on FDA recall #Z-2171-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2171-2026%22&limit=1).
Aniara Diagnostica LLC recalled ZYMUTEST HIA IgG in vitro diagnostic ELISA kits due to outdated flyers containing incorrect positive control values, the FDA said on April 1, 2026. The voluntary Class II recall affects 359 units distributed nationwide.
How to tell if you have it
Brand: Aniara Diagnostica
Product: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit
Reference: RK040A
Lot Number: FD1265
Packaging Date: 17 October 2024
The hazard
Kits from lot FD1265 were packaged on 17 October 2024 and put on the market with an outdated flyer dated 8 October 2024, which contained incorrect values for the positive control.
Context
GovInfoNow's records show Aniara Diagnostica LLC has five other recalls on record since March 19, 2019. Other recent recalls of similar products include the Diagnostica Stago Asserachrom HPIA Kit Recall (Dec. 15, 2025), Immunotech Estrone RIA Kit Recall (Dec. 15, 2025), and Siemens Atellica CH A1c_E Test Recall (June 8, 2026).
How to tell if you have this one
Check for the lot number FD1265 on the kit's packaging. The product was packaged on October 17, 2024, and sold with an outdated flyer from October 8, 2024.
Brand
Aniara Diagnostica
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number FD1265 on the kit's packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Minnesota, Missouri, New Mexico, New York, North Carolina, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2171-2026 (April 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2171-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.