Recall Z-2171-2026— Aniara Diagnostica LLC

Name: FDA recall Z-2171-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-01

Class II · Ongoing

Class II FDA medical device recall by Aniara Diagnostica LLC, initiated 2026-04-01. It names one FDA 510(k) clearance: K071255. Product: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A. Reason: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control..

Recalling firm: Aniara Diagnostica LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-04-01
Firm location: West Chester, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040AHyphen Biomed·cleared 2007-09-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Data sourced from openFDA. This site is unofficial and independent of the FDA.