SP CAL (LIQ) recallZ-2448-2023 · Randox Laboratories Ltd. · initiated Jul 19, 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
As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.
FDA root cause category: Under Investigation by firm
What the company is doing
Randox Labs Ltd (Manufacturer) extended recall to the US distributor via Medical Device Correction Letter dated July 19, 2023. The distributor initial contact with customer and follow up contacts via email and telephone. Letter states reason for recall, health risk and action to take: " Review results generated with the affected batches in line with the clinical profile of the patient. " 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. If you have any questions or concerns please contact Rand ox Technical Services. Any customers using batches 590858 and 590859 for Ferritin, please contact [email protected]
Recall details
- Recall number
- Z-2448-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 19, 2023
- Posted by the FDA
- Aug 23, 2023
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 166 units
- Product code
- JIX
- FDA submissions
- K061056
- Distribution
- CA, FL, IL, ME, MI, NC, OH, PA,NJ,
Product description
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
Code information (models, lots, serial numbers)
GTIN: 05055273204032 Batch/ Lot number Expiry Date 590858 28 08 23; 590859 28 08 23; 627222 28Jul 24; 627224 28Jul24; 634886 28Jul24; 634887 28Jul24
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SP CAL (LIQ) IT2691Randox Laboratories Limited · Calibrator, Multi-Analyte Mixture2 recalls0 reports
Product lines
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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