FDA Medical devices recall ·
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref recall
- Recall number
- Z-2171-2026
- Date
- (initiated April 1, 2026)
- Company / brand
- Aniara Diagnostica LLC
7768 Service Center Dr, West Chester, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 359 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Why was it 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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 03663537018763; Lot Number: FD1265
Distribution
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
States: California Georgia Minnesota Missouri North Carolina New Mexico New York Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2171-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.