FDA Medical Device Recalls (openFDA)
Randox Laboratories: RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
- Recall number
- Z-2059-2018
- Recalling firm
- Randox Laboratories
- Product
- RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
- Status
- Terminated
- Initiated
- 2018-05-04
- Posted
- not on file
- Terminated
- 2020-06-16
- Reason
- Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
- Root cause
- Under Investigation by firm
- Action
- All customers will be contacted directly by email and will be followed up with once every 2 weeks over a period of 6 weeks. Customers are advised to update the software in all analyzers. For further questions, please call 1 (866)472-6369.
- Quantity
- 41 analyzers
- Distribution
- US Distribution including Puerto Rico and the state of : West Virginia.
- Lot, serial or model codes
- GTIN 05055273206104. All serial numbers.
- 510(k) numbers
- ["K052914"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 3003059701
- Firm city
- Kearneysville
- Firm state
- WV
- Firm country
- not on file
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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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