Access Immunoassay System recall
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part…
Why was Access Immunoassay System recalled?
It has been determined that, in some cases, pulley drive components 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640
- Product
- Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 6,858 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of Canada.
- Recall date
- January 2, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)