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Pointe Homocysteine for BS480

HORIBA INSTRUMENTS INCORPORATED · Model 14-H7575-144 · UDI-DI 00811727015877

LPS Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Pointe Homocysteine Reagent packaged for use on the BS480 Analyzer. 2x60mL, 2x12mL, w/calibrator kit. The Liquid Stable 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

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 bias)
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 elevated homocysteine
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 -37% was observed.
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 HOMOCYSTEINE REAGENT lot lis
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 could, in the worst ca

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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.