Lower riskMedical device recall · FDA · Published May 4, 2023
Randox Immunoassay Premium Level 3: Delay in test results due to quality control issues
Randox recalls Immunoassay Premium Level 3 quality control kits for potential delays in test results due to high recovery values outside the acceptable range on Roche Cobas e801 analyzers.
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
Randox is recalling Immunoassay Premium Level 3 quality control kits that may cause delays in test results when used with Roche Cobas e801 analyzers. This happens because the test results show high recovery values outside the expected range, which can lead to inaccurate test reporting. Read more at govinfonow.com/recall/58459-randox-immunoassay-premium-level-3-delay-in-test-results-due.
“Randox Immunoassay Premium Level 3: Delay in test results due to quality control issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58459-randox-immunoassay-premium-level-3-delay-in-test-results-due. Based on FDA recall #Z-2021-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2021-2023%22&limit=1).
The FDA announced on May 4, 2023, that Randox Laboratories Ltd. is recalling Immunoassay Premium Level 3 quality control material due to potential delays in reporting results. The hazard stems from quality controls running high outside the expected range for ACTH testing.
How to tell if you have it
Brand: Randox
Product: Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and
Catalog Number: IA2640
GTIN/UPC: 05055273203868
Lot Code: 2031EC
Expiration Date: 28th Nov 23
Quantity: 1 kit
The hazard
The recall addresses delays in reporting results because quality controls ran high outside of range. This issue affects the target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC when used on the Roche Cobas e801 due to high recovery outside range.
Context
GovInfoNow's records show Randox Laboratories Ltd. has had 49 other recalls since June 7, 2017. Recent brand recalls include a June 7, 2024 recall for missing FDA 510(k) clearance and an April 5, 2024 recall for light leak risks in Evidence MultiSTAT Software v3.7. Other recent recalls of similar products include the Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), the Roche cobas pro integrated solutions recall (Jan. 20, 2026), and the Immunotech Estrone RIA Kit Recall (Dec. 15, 2025).
How to tell if you have this one
Check for the catalog number IA2640 and lot number 2031EC on the kit. The expiration date is November 28, 2023. These kits were sold with Roche Cobas e801 analyzers.
Brand
Randox
Product
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and
Category
Medical device
FDA recall event · 2 products
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
Ongoing
Distribution
CA, IL, VA, WA, WI including PR
Recall number
Product, codes & lots
Quantity
Z-2021-2023
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640; GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23
1 kit
Z-2022-2023
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633; GTIN: 05055273203837 Batch/Lot Number: 583135 Exp. Date: 28th April 23
30 kits
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the catalog number (IA2640) and lot number (2031EC) on the kit to confirm it is recalled.
Where it went and when
Where it was distributed
Distributed in 5 states and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “CA, IL, VA, WA, WI including PR” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Puerto Rico, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2021-2023 (May 4, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2021-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.