Z-2557-2019Class III

Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 -

Name: Z-2557-2019 Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 -
Creator: Randox Laboratories Ltd.
Published: 2019-07-25
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-07-25 / Terminated

FDA source

Randox Laboratories Ltd. began a recall of 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 on 2019-07-25. FDA classified it as Class III and gives the reason as "Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2557-2019
Classification: Class III
Status: Terminated
Initiated: 2019-07-25
Posted: 2019-09-23
Terminated: 2020-12-03
Recalling firm: Randox Laboratories, Limited
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.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
FDA 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 [email protected] within five working days.
Quantity in commerce: 1 kit
Distribution: US Nationwide distribution including the states of IN, WV.
Product codes and lots: Lot: 1020UC Exp. Date: 28 May 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2557-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2557-2019	Class III	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-23

Product code JJW

K110846Class IRandox Urinalysis Controls, Levels 1 and 2Randox Laboratories Limited / cleared 2011-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)