Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported September 18, 2019
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Randox Laboratories Ltd. recalled This is an in vitro diagnostic product intended for use as a calibration serum in clinica… - a low-severity action.
This is an in vitro diagnostic product intended for use as a calibration serum in clinica… was recalled by Randox Laboratories Ltd. in September 18, 2019. Reason: Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line wi…. Check the official notice for the remedy. Verify recall #Z-2490-2019 with the FDA Devices before acting.
The recall
Randox Laboratories Ltd. issued this low-severity FDA Devices recall-Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line wi….
- Low
- severity level
- Class III
- classification
- September 18, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2490-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2490-2019) was formally reported on September 18, 2019, with the manufacturer initiating the action on July 12, 2019. It is classified under Low severity (Class III), 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 307 kits.
The documented reason for this recall is: Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE… Distribution data in the federal record shows the product reached: Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,. 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 - 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 - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
307 kits
Related Recalls
6
0 from same agency
Product description
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Reason for recall
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2490-2019 |
| Date reported | September 18, 2019 |
| Date initiated | July 12, 2019 |
| Recalling firm | Randox Laboratories Ltd. |
| Firm location | Crumlin (North) |
| Affected scope | 307 kits |
| Distribution | Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago, |
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-2490-2019) 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? ▼
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.. Recalled by Randox Laboratories Ltd.. Units affected: 307 kits.
Why was this product recalled? ▼
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2019. Severity: Low. Recall number: Z-2490-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2490-2019) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported September 18, 2019.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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.