AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

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.

Recall #: Z-2966-2020
Affected scope: 143 kits in total
Initiated: July 30, 2020

Compiled from official public sources by the publisher. · Updated September 2026

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Randox Laboratories, LTD. recalled AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determi… - a moderate-severity action.

AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determi… was recalled by Randox Laboratories, LTD. in September 23, 2020. Reason: Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being obs…. Check the official notice for the remedy. Verify recall #Z-2966-2020 with the FDA Devices before acting.

The recall

Randox Laboratories, LTD. issued this moderate-severity FDA Devices recall-Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being obs….

Moderate
severity level: Class II
classification: September 23, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2966-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

Reason for 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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2966-2020
Date reported	September 23, 2020
Date initiated	July 30, 2020
Recalling firm	Randox Laboratories, LTD.
Firm location	Crumlin Colorado Antrim, N/A
Affected scope	143 kits in total
Distribution	US Distribution to states of: VA, UT, WV and country of : Canada

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-2966-2020) 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? ▼

AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma. Recalled by Randox Laboratories, LTD.. Units affected: 143 kits in total.

Why was this product recalled? ▼

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.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 23, 2020. Severity: Moderate. Recall number: Z-2966-2020.

Where was the recalled product distributed? ▼

Distribution: US Distribution to states of: VA, UT, WV and country of : Canada.

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.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

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This recall: FDA Devices, reported September 23, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026