LUMINOSTICS, INC dba CLIP HEALTH: Medical Device Recall in 2022 - (Recall #: Z-0080-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 2, 2022

Date Posted: October 19, 2022

Recall Number: Z-0080-2023

Event ID: 90852

Reason for Recall:

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

Status: Ongoing

Product Quantity: 10037 boxes of 25

Code Information:

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

Distribution Pattern:

US nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated