Immunoassay Premium Level 3-In vitro diagnostic use, as… recallZ-2021-2023 · Randox Laboratories Ltd. · initiated May 4, 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
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
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2021-2023
- Status
- Open, Classified
- Initiated by the company
- May 4, 2023
- Posted by the FDA
- Jun 28, 2023
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1 kit
- Product code
- JJY
- FDA submissions
- K140522
- Distribution
- CA, IL, VA, WA, WI including PR
Product description
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Code information (models, lots, serial numbers)
GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IMMUNOASSAY PREMIUM - LEVEL 3 (IA PREMIUM 3) IA2640Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92344).
- Z-2022-2023 · Open, ClassifiedImmunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
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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