Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 16, 2023
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Randox Laboratories Ltd. recalled Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 … - a moderate-severity action.
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 … was recalled by Randox Laboratories Ltd. in August 16, 2023. Reason: Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -1…. Check the official notice for the remedy. Verify recall #Z-2362-2023 with the FDA Devices before acting.
The recall
Randox Laboratories Ltd. issued this moderate-severity FDA Devices recall-Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -1….
- Moderate
- severity level
- Class II
- classification
- August 16, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2362-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2362-2023) was formally reported on August 16, 2023, with the manufacturer initiating the action on June 13, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Randox Laboratories Ltd. is listed as the recalling firm, operating out of Crumlin (North), N/A. Federal records list the affected scope as 37 US 194 PR.
The documented reason for this recall is: Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after … Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
37 US 194 PR
Related Recalls
6
3 from same agency
Product description
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Reason for recall
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2362-2023 |
| Date reported | August 16, 2023 |
| Date initiated | June 13, 2023 |
| Recalling firm | Randox Laboratories Ltd. |
| Firm location | Crumlin (North), N/A |
| Affected scope | 37 US 194 PR |
| Distribution | US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2362-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena). Recalled by Randox Laboratories Ltd.. Units affected: 37 US 194 PR.
Why was this product recalled? ▼
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 16, 2023. Severity: Moderate. Recall number: Z-2362-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2362-2023) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 16, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.