Z-2167-2017Class III

Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic...

Name: Z-2167-2017 Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic...
Creator: Randox Laboratories
Published: 2017-04-27
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2017-04-27 / Terminated / root cause: labeling and UDI

FDA source

Randox Laboratories began a recall of Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical... on 2017-04-27. FDA classified it as Class III and gives the reason as "According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2167-2017
Classification: Class III
Status: Terminated
Initiated: 2017-04-27
Posted: 2017-05-26
Terminated: 2017-08-14
Recalling firm: Randox Laboratories, Limited
Product: Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Randox Laboratories will contact Customers directly by e-mail and will be followed up with once every 2 weeks over a period of 6 weeks. There are no plans in place to follow up with customers after the 6 week period. For further questions, please call (304) 728-2890.
Quantity in commerce: 198 kits
Distribution: Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq
Product codes and lots: Catalogue number UC5075 Batch number 907UC

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2167-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2167-2017	Class III	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-26

Product code JJY

K110904Class IRandox Liquid Urine Control Levels 2 and 3Randox Laboratories, Ltd. / 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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)