🔍 RecallPedia

DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

Class I - Dangerous
🏥 Medical Devices Recalled: May 22, 2017 Euro Diagnostica AB Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    TS 3577
  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:
FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

Product Codes/Lot Numbers:

TS 3577

Distribution:

Distributed in: MN, TX, NE, PA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2627-2017

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