Severity
Moderate
ModerateClass IITerminated
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-1563-2021) was formally reported on May 19, 2021, with the manufacturer initiating the action on March 29, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Randox Laboratories Ltd. is listed as the recalling firm, operating out of Crumlin (North). Federal records list the affected scope as 98 kits.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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,…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
98 kits
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351. Recalled by Randox Laboratories Ltd.. Units affected: 98 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 19, 2021. Severity: Moderate. Recall number: Z-1563-2021.
Where was the recalled product distributed? ▼
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, Greece, Hong Kong, Iraq, Italy, Ireland, Jordan, Kazakhstan, Kenya, Lithuania, Luxembourg, Mauritius, Mexico, Myanmar, Nepal, New Zealand, Pakistan, Palestine, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, The Netherlands, Turkey, UK, Ukraine, USA, and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1563-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 19, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.