RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Brand
RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom
Lot Codes / Batch Numbers
Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541
Products Sold
Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541
RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom is recalling AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Amm due to Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.
Recommended Action
Per FDA guidance
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 technical.services@randox.com 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: customersupportusa@randox.com and PR at Tel: 1-787-701-7000 Email: Jose.Rosario@randox.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
UT, VA, WV
Page updated: Jan 10, 2026