LUMINOSTICS, INC dba CLIP HEALTH Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.

Recommended Action

Per FDA guidance

On 09/02/2022, Field Safety notices were emailed to customers who were asked to do the following: 1) Locate affected devices in inventory and go to expiry.clipcovid.com to determine the expiration date. 2) Acknowledge receipt and understanding of the notice by emailing sales@cliphealth.com. 3) Share this notice with all those who need to be aware within your organization, or to any organization where the subject devices have been transferred. 4) If you are a distributor, please send proof to Clip Health by September 16th, of your notification to your customers, and their response. Questions or concerns can be emailed to sales@cliphealth.com On 09/21/2022, an updated field safety correction notice was sent to customers. In addition to the information above, customers were asked to do the following: a) Product beyond expiry, as shown on expiry.clipcovid.com, should be quarantined. b) Check this website periodically for potentially extended expiration dates. c) Ensure products are within expiration date claims before use. d) Acknowledge receipt and understanding of the notice using the link provided on the notice.