🔍 RecallPedia

Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

Class I - Dangerous
🏥 Medical Devices Recalled: September 2, 2022 LUMINOSTICS, INC Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: CC-10094-A, CC-10115-A, CC-10123-A, CC-10129-A, CC-10136-A, CC-10144-A, CC-10148-A, CC-10166-A, CC-10168-A, CC-10168-B, CC-10189-A, CC-10193-A, CC-10300-A, CC-10328-A, CC-10329-A, CC-10330-A, CC-10361-A, CC-10364-A, CC-10365-A, CC-10368-A, CC-10369-A, CC-10395-A, CC-10396-A, CC-10397-A, CC-10398-A, CC-10399-A, CC-10439-A, CC-10440-A, CC-10440-B, CC-10441-A, CC-10441-B, CC-10609-A, CC-10609-B, CC-10611-A, CC-10613-A, CC-10615-A, CC-10654-A, CC-10667-A, CC-10710-A, CC-10710-B, CC-10712-A, CC-10714-A, CC-10714-B, CC-10725-A, CC-10727-A, CC-10729-A, CC-10766-A, CC-10768-A, CC-10809-S, CC-10811-S, CC-10874-A, CC-10874-B, CC-10874-C, CC-50002-S, CC-50003-S, CC-50004-S Expiration Dates: expiry.clipcovid.com
  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:
LUMINOSTICS, INC dba CLIP HEALTH
Reason for Recall:
COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

Product Codes/Lot Numbers:

Lots: CC-10094-A, CC-10115-A, CC-10123-A, CC-10129-A, CC-10136-A, CC-10144-A, CC-10148-A, CC-10166-A, CC-10168-A, CC-10168-B, CC-10189-A, CC-10193-A, CC-10300-A, CC-10328-A, CC-10329-A, CC-10330-A, CC-10361-A, CC-10364-A, CC-10365-A, CC-10368-A, CC-10369-A, CC-10395-A, CC-10396-A, CC-10397-A, CC-10398-A, CC-10399-A, CC-10439-A, CC-10440-A, CC-10440-B, CC-10441-A, CC-10441-B, CC-10609-A, CC-10609-B, CC-10611-A, CC-10613-A, CC-10615-A, CC-10654-A, CC-10667-A, CC-10710-A, CC-10710-B, CC-10712-A, CC-10714-A, CC-10714-B, CC-10725-A, CC-10727-A, CC-10729-A, CC-10766-A, CC-10768-A, CC-10809-S, CC-10811-S, CC-10874-A, CC-10874-B, CC-10874-C, CC-50002-S, CC-50003-S, CC-50004-S Expiration Dates: expiry.clipcovid.com

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0080-2023