Recall Z-1298-2022— Haemonetics Corporation
Class II · Terminated
Class II FDA medical device recall by Haemonetics Corporation, initiated 2022-04-19, terminated 2024-03-27. It names 2 FDA 510(k) clearances: K041502, K002177. Product: 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 are viewed using TEG Manager Software (versions 1.1-4.3.1). Reason: 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..
- Recalling firm
- Haemonetics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-04-19
- Terminated
- 2024-03-27
- Firm location
- Boston, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K041502 — THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
- K002177 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 are viewed using TEG Manager Software (versions 1.1-4.3.1)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.