Home › Device types › JIF
Enzymatic Method, Ammonia
FDA product code JIF · Class 1 · Clinical Chemistry
26
Registered devices
51
Adverse events
11
Recalls
30
510(k) clearances
Devices with this code
Ammonia Ultra — SENTINEL CH. SPAADVIA® Chemistry AMM Ammonia Reagents — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge AMM — Siemens Healthcare Diagnostics Inc.Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON Systems — Fisher DiagnosticsAmmonia — Roche Diagnostics GmbHSynchron — Beckman Coulter, Inc.AMMONIA (NH3) — RANDOX LABORATORIES LIMITEDAmmonia II — Roche Diagnostics GmbHAmmonia Standard — CLINIQA CORPORATIONInfinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers — Fisher DiagnosticsAmmonia — Roche Diagnostics GmbHAmmonia — Roche Diagnostics GmbHPOINTE SCIENTIFIC Ammonia Standard 5 — HORIBA INSTRUMENTS INCORPORATEDPOINTE SCIENTIFIC Ammonia Standard 1 — HORIBA INSTRUMENTS INCORPORATEDAMMONIA (NH3) — RANDOX LABORATORIES LIMITEDAmmonia II — Roche Diagnostics GmbHPOINTE SCIENTIFIC AMMONIA — HORIBA INSTRUMENTS INCORPORATEDAmmonia L3K — SEKISUI DIAGNOSTICS, LLCAlinity — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESAtellica CH Amm — Siemens Healthcare Diagnostics Inc.Ammonia II — Roche Diagnostics GmbHNH3 — RANDOX LABORATORIES LIMITEDDimension® Flex® reagent cartridge AMM — Siemens Healthcare Diagnostics Inc.
Recent 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 |
| 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 |
| 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 |
| 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-d |
| 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 |
| 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 rang |
| 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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