Recall Z-1358-2023 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
AGILENT TECHNOLOGIES INC./US
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
| Date | Apr 11, 2023 (initiated Feb 17, 2023) |
| Status | Open, Classified |
| Reason | Distributed sample collection kit with an unapproved instruction for use. |
| Root cause | Labeling Change Control |
| Action | On 02/17/2023, the firm verbally notified its customers that as part of their post-approval commitments to FDA, a final version of the product labeling was submitted to FDA on 01/17/2023. Upon FDA's review of the final label version, FDA deemed the Instruction For Use changes to be significant, such as, changes to allow use of an alternate form to document patient information and modified shipping instructions. On or about 03/23/2023, a formal updated "URGENT: Medical Device Recall" letter will be communicated to customer providing them with the recall details. Customers are instructed to: 1 |
| Quantity | 560 kits |
| Distribution | U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.