| 2022-04-26 |
Class II
|
Terminated |
Z-1310-2022 |
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 |
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Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affec… |
| 2022-04-19 |
Class II
|
Terminated |
Z-1298-2022 |
Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping A… |
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When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the… |
| 2020-02-19 |
Class II
|
Terminated |
Z-1617-2020 |
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: Fo… |
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Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and … |