Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide. Global Distribution. Quantity: 206 units Lot/code info: 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

UPC codes

15099590732103

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.