Haemonetics recalls TEG Manager software versions 1.1.0, 3.0.0, 4.0.0, 4.1.0, and 4.1.1 used with TEG 5000. These versions display out-of-range alerts incorrectly due to rounding errors in reference values.
Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa.
Haemonetics is recalling specific versions of TEG Manager software that work with TEG 5000 devices. The software incorrectly displays test results as out of range when they are actually in range, which could lead to misdiagnosis of blood clotting issues.
The software rounds reference range values to whole numbers, causing it to show an out-of-range alert when the test result is actually within range, or vice versa. This error could lead to incorrect blood clotting test interpretations.
Users of Haemonetics TEG 5000 blood coagulation testing devices with the recalled software versions are affected. Healthcare professionals using these systems for in vitro coagulation studies are most at risk.
Check if your TEG Manager software version is 1.1.0, 3.0.0, 4.0.0, 4.1.0, or 4.1.1 when used with a TEG 5000 device. The software is intended for in vitro coagulation studies.
Identify your TEG Manager software version by checking the device settings or documentation.
No, the recall does not require immediate discontinuation. The software error is low risk and does not cause immediate harm.
The recall does not specify a remedy, so no action is required. Contact Haemonetics for further guidance if you have concerns.
The software may incorrectly display test results as out of range when they are actually in range, or vice versa, potentially leading to misdiagnosis of blood clotting issues.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-1617-2020 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-1617-2020 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.
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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.
