Beckman Coulter Recalls UniCel DxC 600i Synchron Access Clinical Systems
Beckman Coulter is recalling 956 UniCel DxC 600i Synchron Access Clinical Systems because a defective incubator belt pulley may create debris that falls into reaction vessels, potentially causing erroneous 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is erroneous test results, and no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Beckman Coulter Inc. is recalling 956 units of the UniCel DxC 600i Synchron Access Clinical System (P/N 107405S). These in vitro diagnostic devices are used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations in human body fluids. The recall involves specific part numbers A25640, A25638, A25656, and A25637, and includes all serial numbers for these parts.
The recall is initiated due to a defective newly released aluminum incubator belt pulley. This defect may cause the pulley to rub against the light shield, resulting in the formation of debris. This debris can fall into the reaction vessels (RVs), which presents a risk of erroneous test results.
The affected units were distributed worldwide, including nationwide in the United States and in numerous countries across Europe, Canada, and Djibouti. Healthcare facilities and laboratories using these systems should contact Beckman Coulter for further instructions on how to address the defect and ensure the accuracy of their diagnostic testing.
The recalled product
- Product
- UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 956
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 (5)
- Part # A25640
- A25638
- A25656
- A25637
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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