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Pointe Scientific, Inc.
HORIBA INSTRUMENTS INCORPORATED · Model H7575-CTL · UDI-DI 00811727014580
LPS
Prescription
1
510(k) clearances
16
Adverse events
18
Recalls
26
Facilities
Description
Homocysteine Control Kit, is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma. Size: 6 x 1.5 mL
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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Get your free API keyRead the docsData 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.