FDA Device recall Z-0725-2017
Magnesium on RX Imola analyser IVD
- FDA Device
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of Magnesium on RX Imola analyser IVD by Randox Laboratories, citing according to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0725-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-14 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
Magnesium on RX Imola analyser IVD
Reason
According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid wash recommended when setting up the magnesium assay. A correction was made to the IFU for the Magnesium assay and all RX Imola customers in the USA were contacted with the updated instruction.
Identifiers
| code_info | reagent: MG3880 analyser: RX4900 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0725-2017%22
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