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Urinary Homocystine (Nonquantitative) Test System
FDA product code LPS · Class 2 · Clinical Chemistry
46
Registered devices
15
Adverse events
18
Recalls
29
510(k) clearances
Devices with this code
DImension Vista® Homocysteine Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.ST AIA-PACK Homocysteine — TOSOH CORPORATIONPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDDiazyme — DIAZYME LABORATORIES, INC.ARCHITECT — Abbott GmbHHomocysteine Enzymatic Assay — Roche Diagnostics GmbHCAROLINA LIQUID CHEMISTRIES CORP.™ HCY HOMOCYSTEINE REAGENT CC202 — CAROLINA LIQUID CHEMISTRIES CORPORATION3-Reagent Homocysteine Assay for SYNCHRON UniCel — AXIS-SHIELD DIAGNOSTICS LIMITEDARCHITECT — Abbott GmbHAxis® Homocysteine EIA — AXIS-SHIELD DIAGNOSTICS LIMITEDAlinity — Abbott GmbHARCHITECT — Abbott GmbHHomocysteine Enzymatic Assay — Roche Diagnostics GmbHST AIA-PACK Homocysteine Pretreatment Set — TOSOH CORPORATIONMedTest DX Homocysteine Controls — Medtest Dx, Inc.Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent — AXIS-SHIELD DIAGNOSTICS LIMITEDIMMULITE®/IMMULITE® 1000 Systems HCY Homocysteine — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMedTest DX Homocysteine — Medtest Dx, Inc.N Latex HCY — Siemens Healthcare Diagnostics Products GmbHCAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 1 CONTROL KIT PART# CC051 — CAROLINA LIQUID CHEMISTRIES CORPORATIONIMMULITE® 2000 Systems HCY Homocysteine — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — Abbott GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-17 | Roche Diagnostics Operations, Inc. | Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative |
| 2019-10-04 | Roche Diagnostics Operations, Inc. | Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules |
| 2019-09-16 | Axis-Shield Diagnostics, Ltd. | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. |
| 2019-09-16 | Axis-Shield Diagnostics, Ltd. | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. |
| 2019-09-16 | Axis-Shield Diagnostics, Ltd. | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. |
| 2018-11-30 | Tosoh Bioscience Inc | |
| 2017-01-11 | Siemens Healthcare Diagnostics, Inc. | The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or el |
| 2016-05-17 | CSL Behring GmbH | Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of |
| 2015-04-03 | Medtest Holdings, Inc. | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYS |
| 2015-03-23 | Roche Diagnostics Operations, Inc. | Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias co |
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