Z-2346-2019Class II

ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use

Name: Z-2346-2019 ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use
Creator: Aniara Diagnostica LLC
Published: 2019-07-19
License: https://open.fda.gov/license/

Aniara Diagnostica LLC / initiated 2019-07-19 / Terminated

FDA source

Aniara Diagnostica LLC began a recall of ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use on 2019-07-19. FDA classified it as Class II and gives the reason as "Residual crystallization of the microplate and recurrent negative controls out of range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2346-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Posted: 2019-08-22
Terminated: 2021-06-11
Recalling firm: Aniara Diagnostica LLC
Product: ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Product code: LCO Platelet Factor 4 Radioimmunoassay
Reason for recall: Residual crystallization of the microplate and recurrent negative controls out of range.
FDA root cause: Under Investigation by firm
Action: The firm notified customers of the recall via Urgent Medical Device Correction emails dated July 26, 2019. Customers were informed of the recall and asked to destroy the affected kits in stock and indicate the quantity in the Awareness Acknowledgement Form, which was to be signed and returned to the local distributor. If you have any questions regarding this recall, please contact Aniara at (513) 360-6377, or [email protected].
Quantity in commerce: 51
Distribution: Distribution to US states of NC, NH, NY, and OH, and Sweden.
Product codes and lots: F1701084, F1900611

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2346-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2346-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22
Z-2347-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-22

Product code LCO

K071255Class IIZymutest Hia Iggam, Zymutest Igg, Model Rk040d, Rk040aHyphen Biomed / cleared 2007-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)