Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 23, 2020
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-2966-2020) was formally reported on September 23, 2020, with the manufacturer initiating the action on July 30, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Randox Laboratories, LTD. is listed as the recalling firm, operating out of Crumlin Colorado Antrim, N/A. Federal records list the affected scope as 143 kits in total.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Distribution to states of: VA, UT, WV and country of : Canada. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
143 kits in total
Related Recalls
6
0 from same agency
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
| 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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2966-2020) 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 23, 2020.
- 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.