FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
- Recall number
- Z-0905-2023
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
- Status
- Open, Classified
- Initiated
- 2022-11-22
- Posted
- 2023-01-05
- Terminated
- not on file
- Reason
- Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
- Root cause
- Under Investigation by firm
- Action
- Randox Laboratories Ltd issued via email to the US Distributor Randox Laboratories-US, Ltd., Kearneysville, West Virginia on 11/22/22. The US Distributor contacted the customers by letter on 11/28/22. The Urgent Medical Device Correction letter states reason for recall, health risk and action to take: Discard previous IFUs and download the updated IFUs from randox.com Review results generated with the affected batches in line with the clinical profile of the patient. Discuss the contents of this notice with your Medical Director. Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.
- Quantity
- 49 units US
- Distribution
- US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
- Lot, serial or model codes
- GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23; 602LPC 28th Nov 23; 628LPC 28th Dec 24;
- 510(k) numbers
- ["K972608"]
- 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