FDA Device recall Z-0547-2021
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number:…
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number:… by Randox Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0547-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-13 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
Reason
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
Identifiers
| code_info | Lot Number: 539770 Exp. Date : 28 March 2022 UDI: 05055273209303 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0547-2021%22
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