Haemonetics recalls TEG5000 analyzers with specific software versions that may display incorrect PlateletMapping ADP or AA results. Affected users should update software to fix the issue.
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.
Haemonetics is recalling TEG5000 Analyzers with certain software versions that may show incorrect PlateletMapping results. This could lead to inaccurate blood clotting tests, which might affect medical decisions.
The software may display incorrect percentages for PlateletMapping ADP or AA assays when viewing results through TEG Manager. This could lead to inaccurate blood clotting test results, potentially affecting medical decisions.
Healthcare providers using the TEG5000 Analyzer with PlateletMapping ADP or AA assays and TEG Manager Software versions 1.1 to 4.3.1 are most at risk. Patients receiving blood clotting tests may be affected if the results are misinterpreted.
Check for TEG5000 Analyzer model numbers 07-022 or 07-033 with TEG Analytical Software versions 07-030 or 07-031. The issue occurs when using PlateletMapping ADP or AA assays with TEG Manager Software versions 1.1 to 4.3.1.
Install the latest TEG Manager Software version to correct the display issue for PlateletMapping results.
No, you can continue using it but you must update the software to fix the issue.
TEG Manager Software versions 1.1 to 4.3.1 and TEG Analytical Software versions 07-030 and 07-031.
Check your TEG5000 Analyzer model numbers (07-022 or 07-033) and software versions for PlateletMapping ADP or AA assays.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-1298-2022 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-1298-2022 from Haemonetics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
