🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: April 1, 2026 Aniara Diagnostica Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 03663537018763; Lot Number: FD1265
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Aniara Diagnostica LLC
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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

UDI-DI: 03663537018763; Lot Number: FD1265

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2171-2026

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