Z-2965-2020Class II

AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in...

Name: Z-2965-2020 AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in...
Creator: Randox Laboratories, Ltd.
Published: 2020-07-30
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2020-07-30 / Terminated

FDA source

RANDOX LABORATORIES, LTD. began a recall of AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma on 2020-07-30. FDA classified it as Class II and gives the reason as "Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2965-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-30
Posted: 2020-09-14
Terminated: 2021-02-03
Recalling firm: Randox Laboratories, Limited
Product: AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Product code: JIF Enzymatic Method, Ammonia
Reason for recall: 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: 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 [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].
Quantity in commerce: 143 kits in total
Distribution: US Distribution to states of: VA, UT, WV and country of : Canada
Product codes and lots: Catalogue Number: AM1015 GTIN: 05022273200256 Lot #: 517541 batch 517541

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2965-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2965-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-14
Z-2966-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-14

Product code JIF

K030873Class IRandox AmmoniaRandox Laboratories, Ltd. / cleared 2003-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)