🔍 RecallPedia

Ringed DxI Reaction Vessels (RVs)

Class I - Dangerous
🏥 Medical Devices Recalled: June 20, 2023 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334
  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:
Beckman Coulter, Inc.
Reason for Recall:
Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Ringed DxI Reaction Vessels (RVs)

Product Codes/Lot Numbers:

UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2237-2023

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