SP CAL (LIQ) recallZ-0660-2019 · Randox Laboratories Ltd. · initiated Nov 19, 2018
Terminated
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
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
FDA root cause category: Under Investigation by firm
What the company is doing
On November 19, 2018, Randox Laboratories Ltd. issued "Urgent Medical Device Correction" notices and New Calibrator Value sheets (Revised 15 Nov 18 pl) to customers. Customers were advised to take the following action: - Review all remaining stock. Add the notice and replace the calibrator value sheet with the revised document provided. - Discuss the contents of the notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient. - Retain a copy of the letter with laboratory records and forward a copy of the letter to those who may have received this product. - Return the completed response form via email to [email protected]. If you have any questions, contact RA Specialist by email at [email protected].
Recall details
- Recall number
- Z-0660-2019
- Status
- Terminated
- Initiated by the company
- Nov 19, 2018
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 250 kits (32 kits US / 218 kits OUS)
- Product code
- JIX
- FDA submissions
- K031608
- Distribution
- US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
Product description
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Code information (models, lots, serial numbers)
05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SP CAL (LIQ) IT2692Randox Laboratories Limited · Calibrator, Multi-Analyte Mixture1 recall0 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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