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Recall Observatory FDA recall evidence

Device product

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

Z-0080-2023

September 02, 2022

Class II

Product summary

Firm
LUMINOSTICS, INC dba CLIP HEALTH
Event
Event 90852
Status
Ongoing
Classification
Class II
Quantity
10037 boxes of 25
Official record key
device-enforcement:Z-0080-2023

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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