FDAClass IIIApril 19, 2023

Agilent Resolution ctDx FIRST Sample Collection Kit recall

Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

Why was Agilent Resolution ctDx FIRST Sample Collection Kit recalled?

Distributed sample collection kit with an unapproved instruction for use.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model/Part Number: 50032 UDI Code: N/A, single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159

Product
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Recalling firm
AGILENT TECHNOLOGIES INC./US
Quantity
560 kits
Distribution
U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None
Recall date
April 19, 2023
Classification
Class III
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls