Recall Z-1298-2022 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Haemonetics Corporation
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)
| Date | Apr 19, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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. |
| Quantity | 111 |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |