Beckman Coulter Recalls Lactate Reagent Due to Calibration Failures
Beckman Coulter is recalling 3,353 units of SYNCHRON Lactate Reagent because improper storage caused calibration failures, potentially delaying test results.
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 explicitly states the hazard is a delay in reporting results rather than direct physical injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling 3,353 units of SYNCHRON System(s) Lactate (LACT) Reagent, Part Number A95550, Lot Number M210077. The product was distributed nationwide in the United States and in Canada.
The recall was initiated after customer reports indicated that the reagent failed calibration with an 'OCR LOW' error condition. The calibration failures appear to be related to improper shipping or storage conditions, specifically the freezing of the reagent. Failed calibration may cause a delay in reporting lactate concentration results in human plasma and cerebrospinal fluid.
Healthcare facilities and laboratories that have this specific lot of reagent should stop using it and contact Beckman Coulter for instructions on how to return or dispose of the product.
The recalled product
- Product
- SYNCHRON System(s) Lactate (LACT) Reagent. 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 quantitative determination of lactate…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 3,353
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 (2)
- Part Number A95550
- Lot Number M210077
Distribution
Distributed nationwide across the United States.
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