Home / Recalls / Randox Laboratories, Limited / Z-0725-2017

Z-0725-2017 Class II Terminated

Recalled by Randox Laboratories, Limited — Crumlin, N/A

Recall Details

Product Type
Devices
Report Date
December 14, 2016
Initiation Date
April 14, 2016
Termination Date
September 19, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15

Product Description

Magnesium on RX Imola analyser IVD

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution The product was only distributed to US Consignees.

Code Information

reagent: MG3880 analyser: RX4900

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