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Class 2 Device Recall Clip COVID Rapid Antigen Test Kit (25pack), Catalog Number: MDL002 |
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| Date Initiated by Firm |
September 02, 2022 |
| Date Posted |
October 12, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0080-2023 |
| Recall Event ID |
90852 |
| Product Classification |
Coronavirus antigen detection test system. - Product Code QKP
|
| Product |
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 |
| 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 |
Recalling Firm/
Manufacturer |
LUMINOSTICS, INC dba CLIP HEALTH
46430 Fremont Blvd
Fremont CA 94538-6469
|
Manufacturer Reason
for Recall |
COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.
|
FDA Determined
Cause 2 |
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 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. |
| Quantity in Commerce |
10037 boxes of 25 |
| Distribution |
US nationwide distribution
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| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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