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Terminated

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)

FDA Recall Z-1298-2022 · Posted None

Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeJPA
Date Initiated2022-04-19
Date Terminated2024-03-27
Product Quantity111

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.

Firm Action

On April 22, 2022, the firm notified affected customers of the recall via email. Customers were asked to complete and return the attached acknowledgement form. Upon receipt, Haemonetics will contact the customer to arrange the remote installation of the updated software, version 4.4.0, which will resolve the issue.

Root Cause

Software design

Distribution Pattern

US Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAYHaemoscope Corp. · 2004-09-01K002177THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESHaemoscope Corp. · 2000-09-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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