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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Ammonia (NH3), Enzymatic UV Method AM1054

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  Class 2 Device Recall Randox Ammonia (NH3), Enzymatic UV Method AM1054 see related information
Date Initiated by Firm July 30, 2020
Create Date September 14, 2020
Recall Status1 Terminated 3 on February 03, 2021
Recall Number Z-2966-2020
Recall Event ID 86238
510(K)Number K030873  
Product Classification Enzymatic method, ammonia - Product Code JIF
Product AM1054 Randox Ammonia (NH3), Enzymatic UV Method

For the quantitative in vitro determination of Ammonia in plasma
Code Information Catalogue Number: AM1054 GTIN: 05055273200263 Lot #: 512103 batch 512103
Recalling Firm/
Manufacturer		 RANDOX LABORATORIES, LTD.
34 Diamond Rd
Crumlin Colorado Antrim United Kingdom
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 143 kits in total
Distribution US Distribution to states of: VA, UT, WV and country of : Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JIF and Original Applicant = RANDOX LABORATORIES, LTD.
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