Beckman Coulter Access 2 Immunoassay System Recall for Defective Pulley
Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective aluminum incubator belt pulley may create debris that falls into reaction vessels, risking 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 is classified as FDA Class II, and the hazard involves a risk of erroneous test results, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling 3,500 units of the Access 2 Immunoassay System (P/N 107405S 2/12). These in vitro diagnostic devices are used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
The recall is initiated due to a defective newly released aluminum incubator belt pulley. This component may rub against the light shield, causing the formation of debris. This debris can fall into the reaction vessels (RVs), which presents a risk of erroneous test results.
The affected products were distributed worldwide, including the United States (nationwide) and numerous countries in Europe, Canada, and Djibouti. The recall covers Part # 81600N, 386220, A12900, and A69186 with all serial numbers. Users should contact Beckman Coulter for further instructions on how to proceed with the recall.
The recalled product
- Product
- Access 2 Immunoassay System; P/N 107405S 2/12 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
- 3,500
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 # 81600N
- 386220
- A12900
- A69186
- 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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