Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
This recall is currently active, issued September 19, 2023. It was issued by Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland.
- Recall Initiated
- August 3, 2023
- Posted
- September 19, 2023
- Recall Number
- Z-2609-2023
- Quantity
- 66 kits
- Official Source
- View on FDA website ↗
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.
Distribution
US States: GA, OH, OR, PA, TX, VA
Lot / Code Info
UDI-DI: 05055273208986; Lot Number: 1308UE
Root Cause
Under Investigation by firm
Action Taken
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.