DxI 9000 Access Immunoassay Analyzer recall
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Why was DxI 9000 Access Immunoassay Analyzer recalled?
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: 15099590732103; Serial Numbers: 300116-300117, 300123-300124, 300126, 300128-300139, 300141-300145, 300147- 300158, 300160-300164, 300166-300179, 300181-300183, 300186, 300188-300195, 300197-300207, 300209-300250, 300252- 300256, 300258-300259, 300261, 300263- 300264, 300266-300277, 300279-300290, 300291, 300293-300299, 300300-300309, 300312-300352
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 206 units
- Distribution
- US Nationwide. Global Distribution.
- Recall date
- March 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)