FDA Medical Device Recalls (openFDA)
Randox Laboratories, Limited: Magnesium on RX Imola analyser IVD
- Recall number
- Z-0725-2017
- Recalling firm
- Randox Laboratories, Limited
- Product
- Magnesium on RX Imola analyser IVD
- Status
- Terminated
- Initiated
- 2016-04-14
- Posted
- not on file
- Terminated
- 2017-09-19
- 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.
- Root cause
- Device Design
- Action
- Randox sent an Urgent Field Safety Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review and update Rx Imola running order where required. Rework any remaining stock with updated IFU and Important Notice. Complete and return the vigilance response section of the form to technicalservikces@randox.com.
- Quantity
- 15
- Distribution
- Nationwide Distribution The product was only distributed to US Consignees.
- Lot, serial or model codes
- reagent: MG3880 analyser: RX4900
- 510(k) numbers
- ["K052914"]
- PMA numbers
- not on file
- Product code
- JGJ
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28