FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
- Recall number
- Z-2557-2019
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
- Status
- Terminated
- Initiated
- 2019-07-25
- Posted
- not on file
- Terminated
- 2020-12-03
- Reason
- Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
- Root cause
- Under Investigation by firm
- Action
- Randox Laboratories notified the distribution center USA by letter dated July 17, 2019 The distributor contacted the customer directly via email on July 25, 2019. The notification states: reason for recall, health risk and action to take: Discard current revision of the Value Sheet and replace with the revised copy available at www.randox.com " Discuss the contents of this notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days.
- Quantity
- 1 kit
- Distribution
- US Nationwide distribution including the states of IN, WV.
- Lot, serial or model codes
- Lot: 1020UC Exp. Date: 28 May 2020
- 510(k) numbers
- K110846
- PMA numbers
- not on file
- Product code
- JJW
- 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