Liquid Assayed Chemistry Control Premium Plus Level 3… recallZ-2609-2023 · Randox Laboratories Ltd. · initiated Aug 3, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2609-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 3, 2023
- Posted by the FDA
- Sep 19, 2023
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 66 kits
- Product code
- JJY
- FDA submissions
- K140971
- Distribution
- US States: GA, OH, OR, PA, TX, VA
Product description
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Code information (models, lots, serial numbers)
UDI-DI: 05055273208986; Lot Number: 1308UE
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 3 (LIQ CHEM ASY PREMIUM PL LAE4215Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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