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

FDA device recall Z-1928-2019 · posted 2019-07-03 · Terminated

Recall details

Recalling firm

Roche Diagnostics Corporation

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.

Action taken

On April 4, 2019, Roche issued Urgent Medical Device Correction notices (UMDC TP-00620) to customers via UPS Ground (receipt required). Customers were advised to take the following actions: 1) Inspect the tray input flap on the cobas p 501 or p 701 post-analytical unit to determine if it is loose. If it is not fastened securely or becomes loose prior to the part being replaced, contact your Roche Field Engineer Specialist (FES) to repair the instrument. 2) Complete and return the fax form (TP-00621) via fax or email 3) File the UMDC for future reference. Customers with questions may contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in the UMDC.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JQP

Quantity affected

9 units

Distribution

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

Date initiated

2019-04-04

Date posted

2019-07-03

Date terminated

2020-05-12

Location

Indianapolis, IN