CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
Randox Lipoprotein (a) - In vitro diagnostic recalled
Randox Laboratories is recalling Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on, distributed nationwide in the US. The recall was initiated on 20 Dec 2024 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-1018-2025
- FDA event ID
- 96043
- Recalling firm
- Randox Laboratories, Crumlin
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Dec 2024
- FDA classified
- 23 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Dec 2024 | Recall initiated by company | |
| 23 Jan 2025 | Classified by FDA | +34 days |
| 29 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Where it was distributed
US Nationwide distribution Including PR.
Questions about this recall
Why was it recalled?
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Which lots are affected?
UDI-DI: 05055273209198 All lots within expiry
Where was it sold?
US Nationwide distribution Including PR.
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
1 other product · FDA event 96043| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Randox Lipoprotein (a) - In vitro diagnostic recalled | Randox Laboratories | Device Malfunction | Nationwide |
More recalls from Randox Laboratories
All 98| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Randox Lipoprotein (a) - In vitro diagnostic recalled | Randox Laboratories | Device Malfunction | Nationwide |
| 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 |
| Device | CLASS II | Microalbumin Calibrator Series recalled by Randox Laboratories | Randox Laboratories | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |