Randox recalls RX9000 clinical chemistry analyser due to potential incorrect re-run settings causing inaccurate test results. Affected units may need correction to prevent errors in lab testing.
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
“Randox RX Modena-IVD Clinical Chemistry Analyser Recall: Incorrect Re-run Settings Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57365-randox-rx-modena-ivd-clinical-chemistry-analyser-recall-incorrect-re. Based on FDA recall #Z-0201-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0201-2024%22&limit=1).
The FDA announced on Sept. 6, 2023, that Randox Laboratories Ltd. is recalling RX Modena-IVD Clinical Chemistry Analyzers with catalog number RX9000. The hazard involves incorrect sample re-run conditions that may result in reported issues.
The RX Parameter rerun settings and dilutions used for auto reruns may not meet sample re-run conditions when samples are above or below the assay range. This potential issue may result in incorrectly reported results.
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 an Evidence MultiSTAT Software v3.7 recall on April 5, 2024, due to light leak risks. Other recent recalls of similar products include a Siemens Healthcare Syva EMIT 2000 Quinidine Assay recall on July 13, 2026, for inaccurate test results and a Roche cobas pro integrated solutions recall on Jan. 20, 2026, due to software defects causing incorrect lab results.
How to tell if you have this one
Check for the RX9000 model with catalog number RX9000. The recall covers units sold with GTIN: 05055273214963. Lot/batch numbers are not specified in the recall notice.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution including Puerto Rico
Recall number
Product, codes & lots
Quantity
Z-0198-2024
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040; GTIN: 05055273207774 Lot/ Batch Number (1) Lot/ Batch Number 7241-0551 7241-0545 7241-0531 7241-0317 7241-0219
Verify that re-run settings for sample volume and dilutions are correctly configured to avoid inaccurate test results.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution including Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-0201-2024 (September 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0201-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.