Beckman Coulter Access Immunoassay System Recalled for Defective Belt Pulley
Beckman Coulter is recalling Access Immunoassay Systems because a defective belt pulley creates debris that may cause 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 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 limited to erroneous test results without reported injuries or hospitalizations, fitting the Moderate criteria for low-risk issues.
Plain-English summary
Beckman Coulter Inc. is recalling 579 units of the Access Immunoassay System (P/N 107405S). These in vitro diagnostic devices are used to determine analyte concentrations in human body fluids. The recall is due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, causing the formation of debris.
Debris from the rubbing pulley can fall into the reaction vessels, presenting a risk of erroneous test results. The affected units are identified by Part # 81600 and all serial numbers. The products were distributed worldwide, including the United States and numerous countries in Europe, Canada, and Turkey.
No specific consumer action instructions are provided in the source text. Healthcare facilities and users should verify their inventory against the part number and serial information provided.
The recalled product
- Product
- Access Immunoassay 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.
- Hazard
- Affected units
- 579
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 # 81600
- 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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Similar recalls
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