CLASS II ONGOING Device recall · Reported 8 Nov 2023 · FDA Enforcement Report
RX Daytona Plus (without ISE)- IVD Clinical Chemistry recalled
Randox Laboratories is recalling RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (refurbished), distributed nationwide in the US. The recall was initiated on 6 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0199-2024
- FDA event ID
- 93102
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Sep 2023
- FDA classified
- 31 Oct 2023
- Reported
- 8 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 6 Sep 2023 | Recall initiated by company | |
| 31 Oct 2023 | Classified by FDA | +55 days |
| 8 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Where it was distributed
US Nationwide distribution including Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
GTIN: 05055273207781 Lot/Batch: (1) 7241-0616 7241-0582 7241-0441 7241-0425 7241-0384 RX4041R: Lot Number: (2) 7241-0149
Where was it sold?
US Nationwide distribution including Puerto Rico
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 93102This product is part of a recall event; the main page for the event is RX Modena-IVD Clinical Chemistry Analyser recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | RX Modena-IVD Clinical Chemistry Analyser recalled | Randox Laboratories | Potency & Assay | Nationwide | |
| CLASS II | RX Monaco-IVD Clinical Chemistry Analyser recalled | Randox Laboratories | Potency & Assay | Nationwide | |
| CLASS II | RX Imola-IVD Clinical Chemistry Analyzer recalled by Randox Laboratories | Randox Laboratories | Potency & Assay | Nationwide | |
| CLASS II | RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser recalled | Randox Laboratories | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | RX Series CYSC- Cystatin C Reagent -Intended recalled | Randox Laboratories | Potency & Assay | Nationwide |
| Device | CLASS II | Clinical Chemistry Calibration Serum recalled by Randox Laboratories | Randox Laboratories | Other | Nationwide |
| Device | CLASS III | Evidence MultiSTAT recalled by Randox Laboratories | Randox Laboratories | Packaging Defects | Nationwide |
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