CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
RX Series Copper (Cu) Assay recalled by Randox Laboratories
Randox Laboratories is recalling RX Series Copper (Cu) Assay, distributed nationwide in the US. The recall was initiated on 29 Nov 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-0992-2024
- FDA event ID
- 93775
- Recalling firm
- Randox Laboratories, Crumlin (North)
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Nov 2023
- FDA classified
- 6 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Nov 2023 | Recall initiated by company | |
| 6 Feb 2024 | Classified by FDA | +69 days |
| 14 Feb 2024 | 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
Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.
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 Series Copper (Cu) Assay Ref. Number CU2340
Where it was distributed
US Nationwide distribution in the states of SC and OK.
Questions about this recall
Why was it recalled?
Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.
Which lots are affected?
Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;
Where was it sold?
US Nationwide distribution in the states of SC and OK.
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.
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 | 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 |
Other Test Kits & Diagnostics recalls
All 2,663| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |