AM1054 Randox Ammonia (NH3), Enzymatic UV Method recallZ-2966-2020 · Randox Laboratories, Ltd. · initiated Jul 30, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm, Randox Laboratories Ltd., sent an "Urgent Medical Device Correction" letter dated 30th July 2020 to it customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: - Discontinue use of, quarantine and discard any stock of AM1015, batch 517541 and AM1054, batch 512103 immediately. - Review results generated with the affected batches in line with the clinical profile of the patient. - Discuss the contents of this notice with your Medical Director. -Review your reagent inventory of these products and assess your laboratory needs for reimbursement for discarded inventory. -Complete and return the response form 12187-QA to [email protected] within five working days. If you have any questions or concerns please contact Randox Technical Services. Local at Tel: +1 304 728 2890 Toll Free 866 4 RANDOX Email: [email protected] and PR at Tel: 1-787-701-7000 Email: [email protected].
Recall details
- Recall number
- Z-2966-2020
- Status
- Terminated
- Initiated by the company
- Jul 30, 2020
- Recalling firm
- Randox Laboratories, Ltd.
- Quantity
- 143 kits in total
- Product code
- JIF
- FDA submissions
- K030873
- Distribution
- US Distribution to states of: VA, UT, WV and country of : Canada
Product description
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Code information (models, lots, serial numbers)
Catalogue Number: AM1054 GTIN: 05055273200263 Lot #: 512103 batch 512103
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AMMONIA (NH3) AM1054Randox Laboratories Limited · Enzymatic Method, Ammonia1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 86238).
- Z-2965-2020 · TerminatedAM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page