CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report
Randox Mg R1 recalled by Randox Laboratories
Randox Laboratories is recalling Randox Mg R1, distributed nationwide in the US. The recall was initiated on 13 Nov 2020 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-0546-2021
- FDA event ID
- 86827
- Recalling firm
- Randox Laboratories, Crumlin (North), N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Nov 2020
- FDA classified
- 8 Dec 2020
- Reported
- 16 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Nov 2020 | Recall initiated by company | |
| 8 Dec 2020 | Classified by FDA | +25 days |
| 16 Dec 2020 | 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
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
Product as listed by the FDA
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Where it was distributed
US Nationwide distribution in the states of GA, NJ.
Questions about this recall
Is Randox Mg R1 recalled?
Yes. Randox Laboratories recalled Randox Mg R1 on 13 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0546-2021.
Why was it recalled?
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine
Which lots are affected?
Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629
Where was it sold?
US Nationwide distribution in the states of GA, NJ.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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