UniCel DxI 600 Access Immunoassay System Analyzer. The recall
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative…
Why was UniCel DxI 600 Access Immunoassay System Analyzer. The recalled?
The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect 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 Number A30260. Serial Numbers 900781.
- Product
- UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 1 unit
- Distribution
- Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
- Recall date
- February 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)