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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 560
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
Related recalls
Other medical device recalls
- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
Similar recalls
- HighMatrix COVID-19 Test Kits Recalled for Unauthorized Home Sample Collection
FDA (Devices) · 2022-04-27
- ModeratePhilips BrightView XCT Recalled for Intended Use Documentation Mismatch
FDA (Devices) · 2017-02-22
- ModeratePhilips BrightView XCT Medical Device Recalled for Intended Use Labeling Mismatch
FDA (Devices) · 2017-02-22
- ModeratePhilips iCT Computed Tomography System Recalled for Image Labeling Error
FDA (Devices) · 2019-08-14
- SevereFDA Recalls Unauthorized E25Bio COVID-19 Diagnostic Test Kit
FDA (Devices) · 2022-02-16
- SevereFDA Recalls Innova COVID-19 Self-Test Kits Due to Unauthorized Distribution
FDA (Devices) · 2021-06-16