🔍 RecallPedia

ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

Class I - Dangerous
🏥 Medical Devices Recalled: February 20, 2019 Luminex Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot numbers & discontinue use by dates for Part Number 50-10041: AA7313 - Immediately; AA7526 - 3/7/2019; AA7605 - 3/9/2019; AA7631 - 4/3/2019; AA7645 - 4/12/2019
  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:
Luminex Corporation
Reason for Recall:
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

Product Codes/Lot Numbers:

Lot numbers & discontinue use by dates for Part Number 50-10041: AA7313 - Immediately; AA7526 - 3/7/2019; AA7605 - 3/9/2019; AA7631 - 4/3/2019; AA7645 - 4/12/2019

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2286-2019

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