Roche Diagnostics Corporation recalls Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical sy…

Recall date

May 9, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2223-2017

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

US distribution to WA only.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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