The Recall Desk
ModerateFDA (Devices)·Z-1617-2020·Announced 2020-04-08

Haemonetics Recalls TEG Manager Software Due to Alert Display Defect

Haemonetics is recalling TEG Manager software versions 1.1.0 through 4.1.1 because a defect causes incorrect out-of-range alerts for coagulation test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a software display error that could lead to misinterpretation of test results, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Haemonetics Corporation is recalling TEG Manager software versions 1.1.0, 3.0.0, 4.0.0, 4.1.0, and 4.1.1, which are used in conjunction with the TEG 5000 device for in vitro coagulation studies. The recall involves 88 units distributed nationwide in the United States.

The recall is due to a software defect that impacts the displayed alerts for out-of-range test results. Specifically, reference range values received from the TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number. This rounding error can lead the software to display an out-of-range alert when the test result is actually in range, or fail to display an alert when the result is out of range.

Healthcare facilities using these specific software versions should contact Haemonetics Corporation for instructions on how to resolve the defect.

The recalled product

Product
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
Manufacturer
Haemonetics Corporation
Category
Medical Device — Software
Hazard
Affected units
88

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0
  • 3.0.0
  • 4.0.0
  • 4.1.0
  • and 4.1.1.

Distribution

Distributed nationwide across the United States.

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