Magnesium on RX Imola analyser IVD
Reported: December 14, 2016 Initiated: April 14, 2016 #Z-0725-2017
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.
Details
- Recalling Firm
- Randox Laboratories, Limited
- Units Affected
- 15
- Distribution
- Nationwide Distribution The product was only distributed to US Consignees.
- Location
- Crumlin, N/A
Frequently Asked Questions
What product was recalled? ▼
Magnesium on RX Imola analyser IVD. Recalled by Randox Laboratories, Limited. Units affected: 15.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2016. Severity: Moderate. Recall number: Z-0725-2017.
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