Z-2171-2026Class II

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

Name: Z-2171-2026 ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Creator: Aniara Diagnostica LLC
Published: 2026-04-01
License: https://open.fda.gov/license/

Aniara Diagnostica LLC / initiated 2026-04-01 / Open, Classified / root cause: labeling and UDI

FDA source

Aniara Diagnostica LLC began a recall of ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A on 2026-04-01. FDA classified it as Class II and gives the reason as "Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2171-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-01
Posted: 2026-05-12
Recalling firm: Aniara Diagnostica LLC
Product: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Product code: LCO Platelet Factor 4 Radioimmunoassay
Reason for recall: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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 The outdated flyer included in the kit must be immediately removed and destroyed, as well as any paper or electronic copy that could have been done in end-user facility, to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 [email protected].
Quantity in commerce: 359 units
Distribution: US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Product codes and lots: UDI-DI: 03663537018763; Lot Number: FD1265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2171-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2171-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-12

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)