Aniara Diagnostica LLC recalls ZYMUTEST HIA IgG

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

A Field Corrective Action notification letter dated 3/30/26 was sent to customers. Actions implemented by HYPHEN BioMed: -Confirmation of the existence of a flyer discrepancy affecting 95 kits from lot FD1265. - Request for quarantine of the affected kits in US agent warehouse. -Coordination with US agent for notification of the impacted end users. -investigation to define the root cause and to establish corrective and preventive actions. Actions to be implemented by the end user: 1. Check the TAV flyer included in their kit. - If the flyer matches the correct version (dated 18 October 2024) - No action is required. - If the flyer corresponds to the incorrect version (dated I October 2024) - proceed to step 2 2. Destroy the incorrect TAV flyer. The outdated flyer included in the kit must be immediately removed and destroyed, as well as any paper or electronic copy that could have been done in end-user facility, to prevent further use. 3. Replace the incorrect flyer with the corrected version. Use the corrected TAV flyer provided with this notice for all future testing 4. Return the completed and signed form to your local distributor before April 15th, 2026. For any question or information regarding this notification, please contact vigilance team, by email at VigilanceHBM@hyphen-biomed.com.

• FDA enforcement recordOfficial FDA database entry for Z-2171-2026
• FDA 510(k) clearance · K071255The device's official FDA premarket clearance record
• FDA device classification · LCOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.7695The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Aniara Diagnostica LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.