Recall Z-0080-2023 ยท QKP Coronavirus Antigen Detection Test System.
LUMINOSTICS, INC dba CLIP HEALTH
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
| Date | Oct 12, 2022 (initiated Sep 2, 2022) |
| Status | Open, Classified |
| Reason | COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence. |
| Root cause | Incorrect or no expiration date |
| Action | 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 |
| Quantity | 10037 boxes of 25 |
| Distribution | US nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.