Beckman Coulter Recalls Lactate Reagent Due to Error Messages
Beckman Coulter is recalling Lactate Reagent Lot M206209 because it may fail to report numerical values for high lactate concentrations.
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, which typically corresponds to a moderate severity score. The hazard involves a functional error in a diagnostic reagent that could lead to inaccurate results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling 8,774 units of Lactate Reagent, Part Number A95550, Lot Number M206209. This product is used with Synchron LX and UniCel DxC 600/800 Systems for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid.
The recall was initiated after the manufacturer received a customer complaint regarding an error message (RXN RATE HI). This error resulted in no numerical values being reported for samples containing lactate concentrations greater than 6.5 mmol/L.
The affected product was distributed worldwide, including the United States, Canada, Australia, and numerous other countries. Users of this reagent should stop using the affected lot and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quan
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 8,774
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)
- Lot Number: M206209
Distribution
Distributed nationwide across the United States.
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