FDA Recall
Open, Classified
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Recall: Z-2452-2021
·
Initiated March 1, 2021
Recall
- Recall Number
- Z-2452-2021
- Event Number
- 88206
- Firm
- Cellex
- FEI Number
- 3014277758
- Product Code
- QKP
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 1, 2021
- Address
- 507 Airport Blvd, Ste 107, Morrisville, NC, 27560-8200
Description
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Reason
The kit does not have an emergency use authorization (EUA).
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.
Distribution
US Nationwide distribution in the states of CA, FL, TX, and WI.
Quantity
Approximately 44,821 kits