medical MODERATE Updated 2026-05-20

Aniara Diagnostica LLC recalls ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

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Recalled Product

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

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Hazard / Issue

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 03663537018763; Lot Number: FD1265

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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