FDAApril 19, 2022device
Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer ar...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.
What to do
FDA enforcement status: Terminated
Brands named
haemonetics
UPCs
30812747018184
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATEG 5000 Functional Fibrinogen Reagent, Item No. 07-0342022-04-26
- FDATEG 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: For in vitro coagulation studies2020-02-19
- FDAHigh Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.2019-10-21
- FDACS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.2019-10-21
- FDACS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.2019-10-21
- FDACS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.2019-10-21
- FDAJAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell produc...2019-10-21
- FDACell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.2019-10-21
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