AGILENT TECHNOLOGIES INC./US Recall 91863
Description: Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
AGILENT TECHNOLOGIES INC./US Recall 91863 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1358-2023 |
| Event ID | 91863 |
| Event Description | Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None |
| Quantity | 560 kits |
| Recall Reason | Distributed sample collection kit with an unapproved instruction for use. |
| Device Classification | 20230419 |
| Device Code Info | Model/Part Number: 50032 UDI Code: N/A, single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159 |
| Center Classification Date | 20230411 |
| Recall Initiation Date | 20230217 |
| Recalling Firm | AGILENT TECHNOLOGIES INC./US |
| Initial Notification | Letter |
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