CLASS II Device recall · Reported 23 Sep 2020 · FDA Enforcement Report
AM1015 Randox Ammonia (NH3) recalled by Randox Laboratories
Randox Laboratories is recalling AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro, distributed in Utah, Virginia, West Virginia. The recall was initiated on 30 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2965-2020
- FDA event ID
- 86238
- Recalling firm
- Randox Laboratories, Crumlin Colorado Antrim, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jul 2020
- FDA classified
- 14 Sep 2020
- Reported
- 23 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Jul 2020 | Recall initiated by company | |
| 14 Sep 2020 | Classified by FDA | +46 days |
| 23 Sep 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Where it was distributed
US Distribution to states of: VA, UT, WV and country of : Canada
Questions about this recall
Why was it 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 lots are affected?
Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541
Where was it sold?
US Distribution to states of: VA, UT, WV and country of : Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 86238| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AM1054 Randox Ammonia (NH3) recalled by Randox Laboratories | Randox Laboratories | Other | UT, VA, WV |
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