Magnesium on RX Imola analyser IVD — Class II medical device recall Z-0725-2017
Terminated recall by Randox Laboratories, Limited, reported 2016-12-14, distributed nationwide. According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly bef
| Recall number | Z-0725-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Limited, Crumlin, N/A, United Kingdom |
| Recall initiated | 2016-04-14 |
| Classified | 2016-12-08 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2017-09-19 |
| Distributed | Nationwide (US) |
| Quantity | 15 |
| Reason classes | potency |
Product
Magnesium on RX Imola analyser IVD
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0725-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.