UniCel DxC 600i Synchron Access Clinical System recall
UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for…
Why was UniCel DxC 600i Synchron Access Clinical System recalled?
Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
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 # A25640, A25638, A25656, A25637; All Serial Numbers
- Product
- UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 956 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
- Recall date
- April 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)