SP CAL (LIQ)Recalls & reported problems across all models
Randox Laboratories Limited · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one SP CAL (LIQ) model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 2 models of SP CAL (LIQ) by Randox Laboratories Limited in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
SP CAL (LIQ) recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 1, 2024Open, Classified
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Z-1328-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 19, 2023Open, Classified
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.
Z-2448-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 19, 2018Terminated
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.
Z-0660-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
SP CAL (LIQ) models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SP CAL (LIQ) IT2691Calibrator, Multi-Analyte Mixture2 recalls0 reports
- SP CAL (LIQ) IT2692Calibrator, Multi-Analyte Mixture1 recall0 reports
Other Randox Laboratories Limited products
All Randox Laboratories Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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