Z-1107-2019Class III

Liquid Immunoassay Premium Controls, Model Number LIA3105

Name: Z-1107-2019 Liquid Immunoassay Premium Controls, Model Number LIA3105
Creator: Randox Laboratories Ltd.
Published: 2019-02-07
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-02-07 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control... on 2019-02-07. FDA classified it as Class III and gives the reason as "The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1107-2019
Classification: Class III
Status: Terminated
Initiated: 2019-02-07
Posted: 2019-04-08
Terminated: 2020-06-08
Recalling firm: Randox Laboratories, Limited
Product: Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Urgent Medical Device Correction letters dated 2/7/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Randox Technical Services.
Quantity in commerce: 4
Distribution: The products were distributed to the following US states: WV and Puerto Rico.
Product codes and lots: Lot codes: 1723EC

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1107-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1105-2019	Class III	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-08
Z-1106-2019	Class III	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-08
Z-1107-2019	Class III	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-08

Product code JJY

K112337Class IRandox Liquid Immunoassay Premium Controls, Level 1, Level2, Level 3 and Tri LevelRandox Laboratories, Ltd. / cleared 2011-12-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)