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ZYMUTEST HIA IgG ELISA Kit
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MEDICAL DEVICE RECALLMODERATE

ZYMUTEST HIA IgG ELISA Kit

ZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.

What to do

Stop using ZYMUTEST HIA IgG ELISA kit lot FD1265 immediately. Contact Aniara Diagnostica LLC for instructions on kit return or replacement and guidance on any affected test results.

Recalled
Listed
Updated
Recall No.
Z-2171-2026
Agency
FDA
Firm
Aniara Diagnostica LLC
Recall ID
98754
Status
ONGOING

Recall at a glance

Quantity recalled
359 units

Why it was recalled

ZYMUTEST HIA IgG in vitro diagnostic ELISA kit, Ref. RK040A, lot FD1265 was distributed with an outdated instruction flyer (dated 8 October 2024) containing incorrect positive control values. The kit was packaged on 17 October 2024. Incorrect control values may lead to misinterpretation of test results.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Lot code
FD1265
UDI-DI
03663537018763

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-05-13 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification