Recall Z-0080-2023
LUMINOSTICS, INC dba CLIP HEALTH · initiated September 2, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Codes / lots: 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
Reason for recall
COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.
FDA-determined cause: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-0080-2023
- Initiated
- September 2, 2022
- Posted by FDA
- October 12, 2022
- Product code
- QKP – Coronavirus Antigen Detection Test System.
- Quantity
- 10037 boxes of 25
- Distribution
- US nationwide distribution
- Recalling firm
- LUMINOSTICS, INC dba CLIP HEALTH, Fremont, CA