Z-0080-2023Class II

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

Name: Z-0080-2023 Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Creator: LUMINOSTICS, INC dba CLIP HEALTH
Published: 2022-09-02
License: https://open.fda.gov/license/

LUMINOSTICS, Inc dba CLIP HEALTH / initiated 2022-09-02 / Open, Classified

FDA source

LUMINOSTICS, INC dba CLIP HEALTH began a recall of Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 on 2022-09-02. FDA classified it as Class II and gives the reason as "COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0080-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-02
Posted: 2022-10-12
Recalling firm: LUMINOSTICS, Inc dba CLIP HEALTH
Product: Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.
FDA 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 [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.
Quantity in commerce: 10037 boxes of 25
Distribution: US nationwide distribution
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0080-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0080-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-12

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)