Medical device recalls

Roche Diagnostics Corporation recalls cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.

Recall date
April 4, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1928-2019
FDA classification
Class III
Brand / firm
Roche Diagnostics Corporation
Sold / distributed
US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA

Why it was recalled

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.

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