Beckman Coulter Synchron AQUA CAL Level 1 Calibration Kits Recalled
Beckman Coulter is recalling Synchron AQUA CAL Level 1 kits due to a sodium recovery shift that may affect system calibration.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Beckman Coulter Inc is recalling 4,444 kits of Synchron AQUA CAL Level 1, Part No. 471288. These products are used for the system calibration of various analytes, including sodium, potassium, and chloride, in UniCel DxC Systems.
The recall was initiated because the firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1. This issue may impact the accuracy of the calibration process.
The affected products were distributed nationwide in the United States and in several international locations. Users should stop using the recalled kits and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
- Manufacturer
- Beckman Coulter Inc
- Hazard
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)
- Lot No. 72645074
- Exp. Date 30 Apr 2018
Distribution
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