🔍 RecallPedia

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.

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

What Should You Do?

  1. Check if you have this product:
    Lot #'s: TS 2819 (kit) and TS 2841 (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 IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.

Product Codes/Lot Numbers:

Lot #'s: TS 2819 (kit) and TS 2841 (PC)

Distribution:

Distributed in: MN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2921-2018

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is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders

Euro Diagnostica AB

Class I - Dangerous

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

Oct 21, 2016 Infusion Pumps View Details →