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Recall Observatory FDA recall evidence

Device product

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

Z-1928-2019

April 04, 2019

Class III

Product summary

Firm
Roche Diagnostics Corporation
Event
Event 82651
Status
Terminated
Classification
Class III
Quantity
9 units
Official record key
device-enforcement:Z-1928-2019

Official wording

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

Code information: Serial Numbers - 1001 through 1037, and 502

Distribution pattern: US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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