FDAFDA · Food and drugs·Recall number Z-0725-2017
Magnesium on RX Imola analyser IVD
Published December 14, 2016 · Recall initiated: April 14, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories, Limited
- Distributor
- Nationwide Distribution The product was only distributed to US Consignees.
- Lot
- reagent: MG3880 analyser: RX4900
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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