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HemosIL Homocysteine
INSTRUMENTATION LABORATORY COMPANY · Model 00020007800 · UDI-DI 08426950453024
LPS
Prescription
1
510(k) clearances
15
Adverse events
18
Recalls
26
Facilities
Description
HemosIL Homocysteine
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.