Randox Laboratories Ltd.: Medical Device Recall in 2019 - (Recall #: Z-2557-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: July 25, 2019

Date Posted: October 2, 2019

Recall Number: Z-2557-2019

Event ID: 83592

Reason for Recall:

Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.

Status: Terminated

Product Quantity: 1 kit

Code Information:

Lot: 1020UC Exp. Date: 28 May 2020

Distribution Pattern:

US Nationwide distribution including the states of IN, WV.

Voluntary or Mandated:

Voluntary: Firm initiated