Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported May 15, 2024
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled D…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Randox Laboratories Ltd. recalled Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determinatio… - a low-severity action.
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determinatio… was recalled by Randox Laboratories Ltd. in May 15, 2024. Reason: Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not func…. Check the official notice for the remedy. Verify recall #Z-1786-2024 with the FDA Devices before acting.
The recall
Randox Laboratories Ltd. issued this low-severity FDA Devices recall-Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not func….
- Low
- severity level
- 40 units
- affected scope
- Class III
- classification
- May 15, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1786-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1786-2024) was formally reported on May 15, 2024, with the manufacturer initiating the action on April 5, 2024. It is classified under Low severity (Class III), 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 40 units.
The documented reason for this recall is: Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This … Distribution data in the federal record shows the product reached: US Nationwide distribution.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
40 units
Related Recalls
6
3 from same agency
Product description
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
Reason for recall
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-1786-2024 |
| Date reported | May 15, 2024 |
| Date initiated | April 5, 2024 |
| Recalling firm | Randox Laboratories Ltd. |
| Firm location | Crumlin (North), N/A |
| Affected scope | 40 units |
| Distribution | US Nationwide distribution. |
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-1786-2024) 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? ▼
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115. Recalled by Randox Laboratories Ltd.. Units affected: 40 units.
Why was this product recalled? ▼
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2024. Severity: Low. Recall number: Z-1786-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1786-2024) 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 May 15, 2024. 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.