Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
UDI-DI: 05055273208986, Lot Number: 1308UE
Products Sold
UDI-DI: 05055273208986; Lot Number: 1308UE
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 due to there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasm. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 technical.services@randox.com 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, OH, OR, PA, TX, VA
Page updated: Jan 10, 2026