Randox Immunoassay Premium Controls Recall: Stability Issue
Randox recalls Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) due to ACTH stability claims not meeting specifications. Affected lots include IA2633 (398703, 402366), IA2638 (1666EC), IA2639 (1486EC, 1516EC, 1626EC), and IA2640 (1517EC, 1668EC).
Lower-risk recall
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Contact the company
What happened, in plain English
Randox is recalling Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) because the ACTH in these products does not meet the stability claims listed in the product instructions. This could lead to inaccurate test results if the controls are used after the stability period expires. Read more at govinfonow.com/recall/73145-randox-immunoassay-premium-controls-recall-stability-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/73145-randox-immunoassay-premium-controls-recall-stability-issue · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0969-2018
Cite this page
“Randox Immunoassay Premium Controls Recall: Stability Issue.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73145-randox-immunoassay-premium-controls-recall-stability-issue. Based on FDA recall #Z-0969-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0969-2018%22&limit=1).
Why it’s dangerous
The ACTH in the Immunoassay Premium Controls does not maintain stability as claimed in the product instructions. This means the controls might not work properly after the specified stability period, potentially leading to inaccurate test results.
Who’s affected
Lab users who purchased Immunoassay Premium Controls with the specific catalog numbers and lots listed above are affected. Those using these controls for medical testing may be at risk of inaccurate results if the stability claim is not met.
How to tell if you have this one
Check the catalog number on the package, which includes IA2633 (Lots: 398703, 402366), IA2638 (Lot 1666EC), IA2639 (Lots: 1486EC, 1516EC, 1626EC), and IA2640 (Lots 1517EC, 1668EC).
- Brand
Randox- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Distribution US nationwide.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0969-2018 | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages); Catalog numbers: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC) | 117 Kits |
| Z-0970-2018 | Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages); Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979) | 199 Kits |
What to do — step by step
Check Product Lot Numbers
Look for the catalog numbers and lot numbers listed in the recall notice to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distribution US nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0969-2018 (August 11, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0969-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.