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FDAMay 9, 2017device

Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the 5 position racks during the transport. This issue can pose a potential risk to involved operators and can also lead to potential cross contamination of samples in the affected racks.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system — Recall Details · AllClear