FDA recall Z-2557-2019

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.

Reason for recall

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

Distribution

US Nationwide distribution including the states of IN, WV.

Key facts

Status

Terminated

Initiation date

2019-07-25

Report date

2019-10-02

Termination date

2020-12-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2557-2019