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Open, Classified

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

FDA Recall Z-0080-2023 · Posted 2022-10-12

Recall StatusOpen, Classified
Product CodeQKP
Date Initiated2022-09-02
Product Quantity10037 boxes of 25

Reason for Recall

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

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

US nationwide distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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