Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Recall
- Recall Number
- Z-0080-2023
- Event Number
- 90852
- Firm
- LUMINOSTICS, INC dba CLIP HEALTH
- FEI Number
- 3015104453
- Product Code
- QKP
- Status
- Open, Classified
- Root Cause
- Incorrect or no expiration date
- Initiated
- September 2, 2022
- Posted
- October 12, 2022
- Address
- 46430 Fremont Blvd, Fremont, CA, 94538-6469
Description
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.
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 [email protected]. 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 [email protected] 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.
US nationwide distribution
10037 boxes of 25