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FDAApril 14, 2016device

Magnesium on RX Imola analyser IVD

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Magnesium on RX Imola analyser IVD — Recall Details · AllClear