FDA Devices recall · Reported May 19, 2021
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has …
Randox Laboratories Ltd. recalled Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number:… - a moderate-severity action.
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number:… was recalled by Randox Laboratories Ltd. in May 19, 2021. Reason: Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ra…. Check the official notice for the remedy. Verify recall #Z-1563-2021 with the FDA Devices before acting.
The recall
Randox Laboratories Ltd. issued this moderate-severity FDA Devices recall-Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ra….
- Moderate
- severity level
- Class II
- classification
- May 19, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1563-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Reason for recall
Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1563-2021 |
| Date reported | May 19, 2021 |
| Date initiated | March 29, 2021 |
| Recalling firm | Randox Laboratories Ltd. |
| Firm location | Crumlin (North) |
| Affected scope | 98 kits |
| Distribution | Domestic: IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, MS. Foreign: Albania, Argentina, Australia, Bangladesh, Bolivia, Bosnia & Herzegovina, Cameroon, Canada, Colombia, Cyprus, Denmark, Egypt, Estonia, Fiji, France, Germany, Gr… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1563-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026