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Open, Classified

Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"

FDA Recall Z-2452-2021 · Posted None

Recalling FirmCellex
Recall StatusOpen, Classified
Product CodeQKP
Date Initiated2021-03-01
Product QuantityApproximately 44,821 kits

Reason for Recall

The kit does not have an emergency use authorization (EUA).

Firm Action

The recall was initiated via phone. The date the telephone calls were made is unknown but may have occurred late February, early March, 2021, based on the date returns started being made to the recalling firm. The firm issued their initial letters dated 6/15/2021 via email as a result of not having documentation of the phone calls. Later notifications were also issued or verbally discussed, with the latest notification occurring 8/20/2021.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of CA, FL, TX, and WI.

Official Source

View FDA Recall →

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

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