Recall Z-0725-2017 ยท JGJ Photometric Method, Magnesium
Randox Laboratories, Limited
Magnesium on RX Imola analyser IVD
| Date | Apr 14, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Randox sent an Urgent Field Safety Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review and update Rx Imola running order where required. Rework any remaining stock with updated IFU and Important Notice. Complete and return the vigilance response section of the form to technicalservikces@randox.com. |
| Quantity | 15 |
| Distribution | Nationwide Distribution The product was only distributed to US Consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052914 | RX IMOLA Randox Laboratories, Ltd., Mar 31, 2006 |