CLASS II ONGOING Device recall · Reported 22 Sep 2021 · FDA Enforcement Report
qSARS-Cov-2 Antigen Rapid Test, 25 tests/box recalled by Cellex
Cellex is recalling Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to, distributed nationwide in the US. The recall was initiated on 1 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2452-2021
- FDA event ID
- 88206
- Recalling firm
- Cellex, Morrisville, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Mar 2021
- FDA classified
- 13 Sep 2021
- Reported
- 22 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Mar 2021 | Recall initiated by company | |
| 13 Sep 2021 | Classified by FDA | +196 days |
| 22 Sep 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The kit does not have an emergency use authorization (EUA).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Where it was distributed
US Nationwide distribution in the states of CA, FL, TX, and WI.
Questions about this recall
Is qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" recalled?
Yes. Cellex recalled qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" on 1 Mar 2021. The recall is Class II and its status is Ongoing. Recall number Z-2452-2021.
Why was it recalled?
The kit does not have an emergency use authorization (EUA).
Which lots are affected?
All lot numbers
Where was it sold?
US Nationwide distribution in the states of CA, FL, TX, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |