CELLTRION USA INC Recall 89455
Description: Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
CELLTRION USA INC Recall 89455 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0558-2022 |
| Event ID | 89455 |
| Event Description | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of CA. |
| Quantity | 162,000 ea |
| Recall Reason | The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US. |
| Device Classification | 20220209 |
| Device Code Info | All lots |
| Center Classification Date | 20220203 |
| Recall Initiation Date | 20211201 |
| Recalling Firm | CELLTRION USA INC |
| Initial Notification | Letter |
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