Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported April 19, 2023
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Distributed sample collection kit with an unapproved instruction for use.
The recall
Agilent Technologies Inc./us issued this low-severity FDA Devices recall — Distributed sample collection kit with an unapproved instruction for use..
- Low
- severity level
- Class III
- classification
- April 19, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1358-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1358-2023) was formally reported on April 19, 2023, with the manufacturer initiating the action on February 17, 2023. It is classified under Low severity (Class III), with a current status of Ongoing. Agilent Technologies Inc./us is listed as the recalling firm, operating out of Kirkland, WA. Federal records list the affected scope as 560 kits.
The documented reason for this recall is: Distributed sample collection kit with an unapproved instruction for use. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified low severity.
Affected scope
560 kits
Related Recalls
6
6 from same agency
Product description
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Reason for recall
Distributed sample collection kit with an unapproved instruction for use.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-1358-2023 |
| Date reported | April 19, 2023 |
| Date initiated | February 17, 2023 |
| Recalling firm | Agilent Technologies Inc./us |
| Firm location | Kirkland, WA |
| Affected scope | 560 kits |
| Distribution | U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032. Recalled by Agilent Technologies Inc./us. Units affected: 560 kits.
Why was this product recalled? ▼
Distributed sample collection kit with an unapproved instruction for use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Low. Recall number: Z-1358-2023.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1358-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 19, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).