Beckman Coulter Recalls Sekisui Acetaminophen Reagent Due to Carryover
Beckman Coulter is recalling 320 units of Sekisui Acetaminophen reagent because carryover from ACTH reagent may cause falsely elevated Lipase results on the AU 680 analyzer.
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 hazard is a theoretical risk of inaccurate test results (falsely elevated Lipase) with no reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling 320 units of Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K (Ref. 506-30). The product is used in laboratory testing and was distributed nationwide in the United States. The label lists Sekisui Diagnostics (UK) Limited and Sekisui Diagnostics P.E.I. Inc. as firm names.
The recall is due to a potential for reagent carryover. When the Sekisui ACTH reagent is utilized on the BEC AU 680 analyzer, it may lead to falsely elevated BEC Lipase recovery that exceeds the total precision specification. This issue affects all lots of the product.
No illnesses or injuries have been reported. Laboratory professionals should stop using the affected reagent and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 320
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)
- All lots
Distribution
Distributed nationwide across the United States.
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