Magnesium on recall
Magnesium on RX Imola analyser IVD
Why was Magnesium on 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
reagent: MG3880 analyser: RX4900
- Product
- Magnesium on RX Imola analyser IVD
- Recalling firm
- Randox Laboratories, Limited
- Quantity
- 15
- Distribution
- Nationwide Distribution The product was only distributed to US Consignees.
- Recall date
- December 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)