Agilent Resolution ctDx FIRST Sample Collection Kit distributed with unapproved instructions
Agilent Technologies is recalling 560 sample collection kits that were distributed with instructions for use the FDA had not approved.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III device recall with no reported illnesses or injuries. The hazard is regulatory non-compliance (unapproved instructions), not a direct safety defect or contamination. Class III recalls are typically scored 1 or 2; Moderate reflects that incorrect instructions for a medical device could affect proper use, warranting caution despite the absence of reported harm.
Plain-English summary
Agilent Technologies Inc. is recalling 560 Agilent Resolution ctDx FIRST Sample Collection Kits (Model 500032) distributed with unapproved instructions for use. The instructions provided with the kits were not approved by the FDA.
The affected kits were distributed nationwide to facilities in California, Georgia, Indiana, New Jersey, and Texas, with lot numbers 23-0139, 23-0140, 23-0142, 23-0143, and 23-0159.
Individuals and healthcare facilities with these kits should contact Agilent Technologies for information about the recall and guidance on appropriate use or replacement of the kits.
The recalled product
- Product
- Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
- Manufacturer
- AGILENT TECHNOLOGIES INC./US
- Hazard
- unapproved-instructions
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model/Part Number: 50032 UDI Code: N/A
- single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159
Distribution
Distributed nationwide across the United States.
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