Z-2022-2023Class III

Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor...

Name: Z-2022-2023 Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor...
Creator: Randox Laboratories Ltd.
Published: 2023-05-04
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-05-04 / Open, Classified / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes... on 2023-05-04. FDA classified it as Class III and gives the reason as "Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2022-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-05-04
Posted: 2023-06-28
Recalling firm: Randox Laboratories, Limited
Product: Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Randox issued via email to the Distributor Medical Device Correction Letter and forwarded to US and PR customers on 04 May, 2023. Letter states reason for recall, health risk and action to take: Discontinue use of and discard the current IFU and download the updated IFU from randox.com Discuss the contents of this notice with your Medical Director. Complete and return the response for 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. If you have any questions or concerns please contact Randox Technical Services.
Quantity in commerce: 30 kits
Distribution: CA, IL, VA, WA, WI including PR
Product codes and lots: GTIN: 05055273203837 Batch/Lot Number: 583135 Exp. Date: 28th April 23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2022-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2021-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-28
Z-2022-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-28

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