Recall Z-2557-2019— Randox Laboratories Ltd.

Name: FDA recall Z-2557-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-25

Class III · Terminated

Class III FDA medical device recall by Randox Laboratories Ltd., initiated 2019-07-25, terminated 2020-12-03. It names one FDA 510(k) clearance: K110846. 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: Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+..

Recalling firm: Randox Laboratories Ltd.
Classification: Class III
Status: Terminated
Initiated: 2019-07-25
Terminated: 2020-12-03
Firm location: Crumlin (North), Ireland

510(k) clearances named in this recall

1 on FDA's record

K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories Limited·cleared 2011-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.