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Randox Laboratories, Limited recalls Magnesium on RX Imola analyser IVD
Recalled December 14, 2016 · FDA recall Z-0725-2017 · Randox Laboratories
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. · FDA Class II
Units
15
Sold at
Nationwide Distribution The product was only distributed to US Consignees.
Description
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.
Product
Magnesium on RX Imola analyser IVD
Manufacturer(s)
Randox Laboratories, Limited
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →