Lower riskMedical device recall · FDA · Published April 5, 2024
Randox Evidence MultiSTAT Software v3.7 Recall: Light Leak Risk in Drug Testing
Randox recalls Evidence MultiSTAT drug testing devices with software v3.7 due to potential light leaks affecting test results. Affected units may delay reporting results.
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.
Randox is recalling Evidence MultiSTAT drug testing devices with software version 3.7 because foam gaskets in the chip heater assembly might not work properly. This could cause light to leak into the camera during testing, leading to inaccurate results and delayed reporting. Read more at govinfonow.com/recall/55575-randox-evidence-multistat-software-v3-7-recall-light-leak-risk.
“Randox Evidence MultiSTAT Software v3.7 Recall: Light Leak Risk in Drug Testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55575-randox-evidence-multistat-software-v3-7-recall-light-leak-risk. Based on FDA recall #Z-1786-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1786-2024%22&limit=1).
The FDA announced on April 5, 2024, that Randox Laboratories Ltd. is recalling Evidence MultiSTAT with software v 3.7-Analyzer devices due to a faulty foam gasket hazard. The agency classified the recall as Class III.
How to tell if you have it
Brand: Randox
Product: Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine
According to the FDA, a foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. This defect may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging, affecting testing and delaying result reporting.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include a Cystatin C Reagent recall on June 7, 2024, for missing FDA 510(k) clearance and a Clinical Chemistry Calibration Serum recall on March 5, 2024, involving an inorganic phosphate bias issue. Other recent recalls of similar products include an ICU Medical Hotline Fluid Warming Set recall (June 24, 2026), a Philips Azurion System recall (April 28, 2026), and a Milestone Vacuum Bag SU Large Specimen Container recall (March 9, 2026).
How to tell if you have this one
Check for the Evidence MultiSTAT device with software version 3.7. Serial numbers include 052-23-0424 through 052-23-0609 (as listed in the recall notice).
Brand
Randox
Product
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Verify your Evidence MultiSTAT device's serial number against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1786-2024 (April 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1786-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.