Reported Dec 14, 2016 · Terminated
Magnesium on RX Imola analyser IVD
Randox Laboratories, Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories, Limited · Ardmore 55 The Diamond Road · Crumlin, N/A · N/A
Is this the product you have?
- Magnesium on RX Imola analyser IVD
- Lot codes and dates
- reagentMG3880
- analyserRX4900
- Amount recalled
- 15
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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