Randox Laboratories, Limited recalls Magnesium on RX Imola analyser IVD

Recall date

April 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0725-2017

FDA classification

Class II

Brand / firm

Randox Laboratories, Limited

Sold / distributed

Nationwide Distribution The product was only distributed to US Consignees.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Magnesium on RX Imola analyser IVD