TEG5000 Analyzer displays incorrect PlateletMapping assay results in TEG Manager
Haemonetics' TEG5000 Analyzer displays incorrect PlateletMapping assay values when connected to TEG Manager Software versions 1.1–4.3.1, potentially affecting laboratory test interpretation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported injuries or illnesses. The hazard is a software display error in a clinical laboratory device that could affect diagnostic accuracy, representing a risk-of-harm where injury has not yet been reported.
Plain-English summary
The TEG5000 Analyzer, a blood clotting measurement device manufactured by Haemonetics Corporation, is being recalled. When used with PlateletMapping Assays (ADP and AA variants) and TEG Manager Software, the device displays incorrect values for PlateletMapping ADP or AA percent inhibition and percent aggregation.
The error occurs when PlateletMapping Assay results from a TEG5000 analyzer are viewed using TEG Manager Software versions 1.1 through 4.3.1. Incorrect laboratory test results could affect clinical decision-making in healthcare and laboratory settings. Approximately 111 units are affected nationwide.
A correction for this issue has been issued by Haemonetics. The correction applies specifically to systems using TEG Manager Software versions 1.1 through 4.3.1 with affected PlateletMapping assay configurations.
The recalled product
- Product
- 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
- Manufacturer
- Haemonetics Corporation
- Hazard
- software-error
- measurement-error
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 (4)
- This correction is applicable when TEG 5000 PlateletMapping (Item # 07-014
- 07-015
- 07-016) is performed on a TEG 5000 analyzer (Item # 07-022
- TAS v4.2.3
Distribution
Distributed nationwide across the United States.
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