Z-1358-2023Class III

Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

Name: Z-1358-2023 Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Creator: Agilent Technologies Inc./us
Published: 2023-02-17
License: https://open.fda.gov/license/

Agilent Technologies Inc./US / initiated 2023-02-17 / Open, Classified / root cause: labeling and UDI

FDA source

AGILENT TECHNOLOGIES INC./US began a recall of Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 on 2023-02-17. FDA classified it as Class III and gives the reason as "Distributed sample collection kit with an unapproved instruction for use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1358-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-02-17
Posted: 2023-04-11
Recalling firm: Agilent Technologies Inc./US
Product: Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: Distributed sample collection kit with an unapproved instruction for use.
Root cause tag: labeling and UDI
FDA 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. Stop use of Sample Collection Kits and place under quarantine (see Table 1 for affected product and lot numbers). 2. Complete the following four (4) records and return them to Resolution s Quality Team at [email protected]: i. Attachment 1, Recall Acknowledgement and Customer Return Form: Confirm that you have received this notification by returning enclosed acknowledgement form within 3 business days of receipt, answering the questions, documenting the inventory quantities, and completing the acknowledgement box. ii. Prepare the inventory for return according to provided instructions in Attachment 2, Shipping Instructions iii. Attachment 3, Product Return - Shipping Record: For each lot number and Quest Hub location, record the number of unused products being returned, shipped by and date, shipping tracking number, scan attachment 3 and email to [email protected], include attachment 3 with the shipment. iv. Attachment 4, Certification of Product Destruction Record: If there are any devices that were opened or in the process of being used please document their destruction in this attachment, scan and return via email to [email protected]. Destroy devices following your laboratory procedures as deemed appropriate by your company. For questions, contact Agilent Corporate Communications at 669-225-7696 or via emails at [email protected]
Quantity in commerce: 560 kits
Distribution: U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None
Product codes and lots: Model/Part Number: 50032 UDI Code: N/A, single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1358-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1358-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-11

Product code PQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)