Recall Z-0725-2017— Randox Laboratories, Limited
Class II · Terminated
Class II FDA medical device recall by Randox Laboratories, Limited, initiated 2016-04-14, terminated 2017-09-19. It names one FDA 510(k) clearance: K052914. Product: Magnesium on RX Imola analyser IVD. Reason: 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..
- Recalling firm
- Randox Laboratories, Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-14
- Terminated
- 2017-09-19
- Firm location
- Crumlin, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.