Recall Z-2347-2019— Aniara Diagnostica LLC

Name: FDA recall Z-2347-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-19

Class II · Terminated

Class II FDA medical device recall by Aniara Diagnostica LLC, initiated 2019-07-19, terminated 2021-06-11. It names one FDA 510(k) clearance: K071255. Product: ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.. Reason: Residual crystallization of the microplate and recurrent negative controls out of range..

Recalling firm: Aniara Diagnostica LLC
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Terminated: 2021-06-11
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 MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.

Reason for recall

Residual crystallization of the microplate and recurrent negative controls out of range.

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