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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Haemonetics Corporation
- Affected units
- 111
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.
Related recalls
Same manufacturer · Haemonetics Corporation
See all →- HighFDA Recalls TEG 5000 Fibrinogen Reagent Kits Due to Outdated Reference Ranges
FDA (Devices) · 2022-07-06
- ModerateHaemonetics Recalls TEG Manager Software Due to Alert Display Defect
FDA (Devices) · 2020-04-08
- HighHaemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks
FDA (Devices) · 2020-02-05
- HighHaemonetics Recalls Japan Disp Sets Due to Potential Bowl Cracks
FDA (Devices) · 2020-02-05
- HighHaemonetics Recalls Cell Saver 5/5+ Bowl Kits Due to Leak Risk
FDA (Devices) · 2020-02-05
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateHaemonetics Recalls TEG Manager Software Due to Alert Display Defect
FDA (Devices) · 2020-04-08
- ModerateHaemonetics Recalls TEG 5000 Analyzers Due to Manual Errors
FDA (Devices) · 2013-07-31
- HighFDA Recalls TEG 5000 Fibrinogen Reagent Kits Due to Outdated Reference Ranges
FDA (Devices) · 2022-07-06
- HighRadiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors
FDA (Devices) · 2020-06-03
- SevereBeckman Coulter UniCel DxH 800 Hematology Analyzer Recall for Platelet Errors
FDA (Devices) · 2019-05-29
- HighSTA R Max Analyzer Firmware Bug Produces Inaccurate Coagulation Test Results
FDA (Devices) · 2023-05-17