FDA Medical Device Recalls (openFDA)
Randox Laboratories: Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
- Recall number
- Z-0970-2018
- Recalling firm
- Randox Laboratories
- Product
- Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
- Status
- Terminated
- Initiated
- 2017-08-11
- Posted
- not on file
- Terminated
- 2019-03-29
- Reason
- The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
- Root cause
- Device Design
- Action
- On July 24, 2017 an Urgent notice was issued instructing customers to place a copy a notice in all kits remaining in stock. This notifies customers that they should amend the claims for open stability in the instructions for use, to state use immediately after the 30 minute reconstitution period. Questions or concerns can be emailed to technical.services@randox.com
- Quantity
- 199 Kits
- Distribution
- Distribution US nationwide.
- Lot, serial or model codes
- Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979)
- 510(k) numbers
- ["K140522"]
- PMA numbers
- not on file
- Product code
- JJY
- 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