Beckman Coulter Recalls Access Immunoassay Systems Due to Pulley Defects
Beckman Coulter is recalling Access Immunoassay Systems because pulley drive components may break or disconnect, causing inadequate washing or mixing.
What this means for you
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 defect poses a risk of harm through inadequate washing or mixing, but the source text does not report any injuries or illnesses.
Plain-English summary
Beckman Coulter Inc. is recalling 6,858 units of Access Immunoassay Systems, Access 2 Immunoassay Systems, Synchron LXi 725 Clinical Systems, and UniCel DxC 600i Synchron Access Clinical Systems. The affected units were distributed nationwide in the United States and in Canada.
The recall was initiated because pulley drive components in some units have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.
The source text does not specify instructions for consumers or healthcare facilities regarding the immediate handling of these devices.
The recalled product
- Product
- Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 6,858
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 (9)
- Part Numbers: Access 81600
- Access 2 81600N
- 386220
- A69186
- A25656
- A12900
- Access 2 (LXi) A15642
- Access 2 Section
- DxC 600i A25640
Distribution
Distributed nationwide across the United States.
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