Roche Diagnostics Corporation: Medical Device Recall in 2019 - (Recall #: Z-1927-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

Product Classification:

Class III

Date Initiated: April 4, 2019

Date Posted: July 10, 2019

Recall Number: Z-1927-2019

Event ID: 82651

Reason for Recall:

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

Status: Terminated

Product Quantity: 4 units

Code Information:

Serial Numbers - 1001 through 1044

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated