Recall Z-1358-2023— AGILENT TECHNOLOGIES INC./US
Class III · Ongoing
Class III FDA medical device recall by AGILENT TECHNOLOGIES INC./US, initiated 2023-02-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Agilent Resolution ctDx FIRST Sample Collection Kit, 500032. Reason: Distributed sample collection kit with an unapproved instruction for use..
- Recalling firm
- AGILENT TECHNOLOGIES INC./US
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2023-02-17
- Firm location
- Kirkland, WA, United States
Product description
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Reason for recall
Distributed sample collection kit with an unapproved instruction for use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.