Recall Z-2452-2021 ยท QKP Coronavirus Antigen Detection Test System.
Cellex
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
| Date | Mar 1, 2021 |
| Status | Open, Classified |
| Reason | The kit does not have an emergency use authorization (EUA). |
| Root cause | Under Investigation by 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. |
| Quantity | Approximately 44,821 kits |
| Distribution | US Nationwide distribution in the states of CA, FL, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.