Magnesium on RX Imola analyser IVD
FDA Recall Z-0725-2017 · Posted None
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Recalling FirmRandox Laboratories, Limited
Recall StatusTerminated
Product CodeJGJ
Date Initiated2016-04-14
Date Terminated2017-09-19
Product Quantity15
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.
Firm 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 [email protected].
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution The product was only distributed to US Consignees.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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