🔍 RecallPedia

Vaginal Verification Panel Ref 8208 Lot 8208-11

Class I - Dangerous
🏥 Medical Devices Recalled: January 3, 2020 Microbiologics Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot 8208-11
  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:
Microbiologics Inc
Reason for Recall:
Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Vaginal Verification Panel Ref 8208 Lot 8208-11

Product Codes/Lot Numbers:

Lot 8208-11

Distribution:

Distributed in: US, CA, KS, ME, NC, NY, OR, UT, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1096-2020

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