CLASS I Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
Celltrion DiaTrust Covid-19 Ag Rapid Test recalled
Celltrion USA is recalling Celltrion DiaTrust Covid-19 Ag Rapid Test, Reference No. CT-P60 D-2 02, distributed in Texas. The recall was initiated on 2 Dec 2021 and the FDA has classified it as Class I.
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-0680-2022
- FDA event ID
- 89516
- Recalling firm
- Celltrion USA, Jersey City, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Dec 2021
- FDA classified
- 2 Mar 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Dec 2021 | Recall initiated by company | |
| 2 Mar 2022 | Classified by FDA | +90 days |
| 9 Mar 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
Product as listed by the FDA
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Where it was distributed
Distributed to TX.
Questions about this recall
Why was it recalled?
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
Which lots are affected?
Lots COVGCCF0001, COVGCCF0002
Where was it sold?
Distributed to TX.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Celltrion USA
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Celltrion DiaTrust Covid-19 Ag Rapid Test recalled | Celltrion USA | Other | Nationwide |
| Device | CLASS II | Celltrion DiaTrust Covid-19 Ag Rapid Test recalled | Celltrion USA | Other | 11 states |
| Device | CLASS I | Celltrion DiaTrust Covid-19 Ag Rapid Test recalled | Celltrion USA | Other | 6 states |
| Device | CLASS II | Celltrion DiaTrust Covid-19 Ag Rapid Test recalled | Celltrion USA | Hidden Drug Ingredients | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein 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 | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |