🔍 RecallPedia

Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

Class I - Dangerous
🏥 Medical Devices Recalled: March 15, 2021 Medline Industries Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000
  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:
Medline Industries Inc
Reason for Recall:
Possible false negative or false positive results due to the product being compromised during shipment.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

Product Codes/Lot Numbers:

Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1407-2021

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