FDA-Device2016-12-14Class II
Magnesium on RX Imola analyser IVD
Randox Laboratories, Limited
Hazard
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.
Sold states
Nationwide Distribution The product was only distributed to US Consignees.
Affected count
15
Manufactured in
Ardmore 55 The Diamond Road, N/A, Crumlin, N/A, United Kingdom
Products
Magnesium on RX Imola analyser IVD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0725-2017Don't want to check this manually?
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