Z-2609-2023Class II

Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

Name: Z-2609-2023 Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Creator: Randox Laboratories Ltd.
Published: 2023-08-03
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-08-03 / Open, Classified / root cause: labeling and UDI

FDA source

Randox Laboratories Ltd. began a recall of Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 on 2023-08-03. FDA classified it as Class II and gives the reason as "there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2609-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-03
Posted: 2023-09-19
Recalling firm: Randox Laboratories, Limited
Product: Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: A Medical Device Correction notification letter dated 8/3/23 was sent to customers. Action to be taken: " Review Quality Control data generated using the affected lot. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 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 organisation. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concerns please contact Randox Technical Services.
Quantity in commerce: 66 kits
Distribution: US States: GA, OH, OR, PA, TX, VA
Product codes and lots: UDI-DI: 05055273208986; Lot Number: 1308UE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2609-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2609-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-19

Product code JJY

K140971Class ILiquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.Randox Laboratories Limited / cleared 2014-12-08

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)