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Recall Observatory FDA recall evidence

Device product

Magnesium on RX Imola analyser IVD

Z-0725-2017

April 14, 2016

Class II

Product summary

Firm
Randox Laboratories, Limited
Event
Event 75263
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-0725-2017

Official wording

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.

Code information: reagent: MG3880 analyser: RX4900

Distribution pattern: Nationwide Distribution The product was only distributed to US Consignees.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.