LUMINOSTICS, INC dba CLIP HEALTH Recall 90852
Description: Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
LUMINOSTICS, INC dba CLIP HEALTH Recall 90852 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0080-2023 |
| Event ID | 90852 |
| Event Description | Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 |
| Product Type | Devices |
| Distribution | US nationwide distribution |
| Quantity | 10037 boxes of 25 |
| Recall Reason | COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence. |
| Device Classification | 20221019 |
| Device Code Info | 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 |
| Center Classification Date | 20221012 |
| Recall Initiation Date | 20220902 |
| Recalling Firm | LUMINOSTICS, INC dba CLIP HEALTH |
| Initial Notification | Letter |
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