Randox Ammonia Reagents Recall: Positive Bias in Patient Samples
Randox recalls AM1015 Ammonia reagents due to potential positive bias in patient samples. This may lead to inaccurate ammonia levels in blood tests. Affected units include specific lot numbers.
Lower-risk recall
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
Contact the company
What happened, in plain English
Randox is recalling its AM1015 Ammonia reagents because they can show up to 140 mol/l higher ammonia levels in patient samples than they should. This could lead to incorrect blood test results, which might affect diagnosis and treatment decisions. Read more at govinfonow.com/recall/64591-randox-ammonia-reagents-recall-positive-bias-in-patient-samples.
Source Summary by GovInfoNow · govinfonow.com/recall/64591-randox-ammonia-reagents-recall-positive-bias-in-patient-samples · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2965-2020
Cite this page
“Randox Ammonia Reagents Recall: Positive Bias in Patient Samples.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64591-randox-ammonia-reagents-recall-positive-bias-in-patient-samples. Based on FDA recall #Z-2965-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2965-2020%22&limit=1).
Why it’s dangerous
The reagents can produce a positive bias of up to 140 mol/l in patient samples. This means test results might show higher ammonia levels than actually present, potentially leading to incorrect medical decisions.
Who’s affected
Patients using Randox AM1015 Ammonia reagents for blood tests may be affected. Those with specific lot numbers (517541) are most at risk.
How to tell if you have this one
Check for the lot number 517541 on the reagent packaging. The product is sold under the catalog number AM1015 and GTIN 05022273200256.
- 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 II- Status
Terminated- Distribution
US Distribution to states of: VA, UT, WV and country of : Canada
| Recall number | Product, codes & lots |
|---|---|
| Z-2965-2020 | AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma; Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541 |
| Z-2966-2020 | AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma; Catalogue Number: AM1054 GTIN: 05055273200263 Lot #: 512103 batch 512103 |
What to do — step by step
Check Reagent Lot Number
Look for the lot number 517541 on the reagent packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
FDA distribution: “US Distribution to states of: VA, UT, WV and country of : Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Utah, Virginia, West Virginia.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-2965-2020 (July 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2965-2020 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.