Z-0970-2018Class III

Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

Name: Z-0970-2018 Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Creator: Randox Laboratories
Published: 2017-08-11
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2017-08-11 / Terminated / root cause: design

FDA source

Randox Laboratories began a recall of Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) on 2017-08-11. FDA classified it as Class III and gives the reason as "The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0970-2018
Classification: Class III
Status: Terminated
Initiated: 2017-08-11
Posted: 2018-03-12
Terminated: 2019-03-29
Recalling firm: Randox Laboratories, Limited
Product: Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Root cause tag: design
FDA root cause: Device Design
Action: On July 24, 2017 an Urgent notice was issued instructing customers to place a copy a notice in all kits remaining in stock. This notifies customers that they should amend the claims for open stability in the instructions for use, to state use immediately after the 30 minute reconstitution period. Questions or concerns can be emailed to [email protected]
Quantity in commerce: 199 Kits
Distribution: Distribution US nationwide.
Product codes and lots: Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0970-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0969-2018	Class III	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-12
Z-0970-2018	Class III	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-12

Product code JJY

K140522Class IRandox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium Plus Tri-Level ControlRandox Laboratories Limited / cleared 2014-05-22

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)