Haemonetics Recalls TEG 5000 Analyzers Due to Manual Errors
Haemonetics is recalling 1,590 TEG 5000 Thromboelastograph Coagulation Analyzers because the user manual incorrectly included Research Use Only parameters.
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 2/5 (Moderate).
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, but the source text does not report any hospitalizations or injuries, and the hazard is limited to documentation errors in the user manual, fitting the criteria for a moderate severity score.
Plain-English summary
Haemonetics Corporation is recalling 1,590 TEG 5000 Thromboelastograph Coagulation Analyzers. These devices are multipurpose systems used for in vitro coagulation studies. The recall was initiated because the TEG 5000 User Manual included Research Use Only (RUO) parameters.
The affected devices were distributed nationwide in the United States. The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not specify any reported illnesses, injuries, or deaths associated with this recall.
Users of the TEG 5000 Thromboelastograph Coagulation Analyzer should stop using the device and contact Haemonetics Corporation for further instructions on how to proceed with the recall.
The recalled product
- Product
- TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
- Manufacturer
- Haemonetics Corporation
- Hazard
- Affected units
- 1,590
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 (1)
- Per recall strategy.
Distribution
Distributed nationwide across the United States.
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