FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
- Recall number
- Z-1107-2019
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
- Status
- Terminated
- Initiated
- 2019-02-07
- Posted
- not on file
- Terminated
- 2020-06-08
- Reason
- The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
- Root cause
- Employee error
- Action
- Urgent Medical Device Correction letters dated 2/7/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Randox Technical Services.
- Quantity
- 4
- Distribution
- The products were distributed to the following US states: WV and Puerto Rico.
- Lot, serial or model codes
- Lot codes: 1723EC
- 510(k) numbers
- ["K112337"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
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