🔍 RecallPedia

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

Class I - Dangerous
🏥 Medical Devices Recalled: October 21, 2016 Euro Diagnostica AB Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Lot #'s: TS2725 (kit) and TS 2733 (PC)
  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:
Euro Diagnostica AB
Reason for Recall:
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

Product Codes/Lot Numbers:

Lot #'s: TS2725 (kit) and TS 2733 (PC)

Distribution:

Distributed in: MN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2919-2018

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