Ammonia Ultra

SENTINEL CH. SPA · Model 17660 · UDI-DI 08058056680181

JIF Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The Ammonia Ultra assay is intended for the in vitro quantitative enzymatic determination of ammonia in human plasma using an automated analyzer. Measurements of ammonia are used to aid in the diagnosis of patients suspected of having hyperammonemia. For laboratory professional use only.

Recalls

Date	Firm	Reason
2020-07-30	RANDOX LABORATORIES, LTD.	Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.
2020-07-30	RANDOX LABORATORIES, LTD.	Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being observed on patient samples.
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2016-12-16	Siemens Healthcare Diagnostics, Inc.	Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration inter
2016-12-16	Siemens Healthcare Diagnostics, Inc.	Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interva
2016-11-29	Sekisui Diagnostics P.E.I. Inc.	Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
2015-09-22	Sentinel CH SpA	Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
2009-03-26	Beckman Coulter Inc.	The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.