🔍 RecallPedia

is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma 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: TS 1740 (kit) and TS 1743 (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 qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

Product Codes/Lot Numbers:

Lot #'s: TS 1740 (kit) and TS 1743 (PC)

Distribution:

Distributed in: MN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2922-2018

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