cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
- Company
- Roche Diagnostics Corporation
- Recall Initiated
- April 4, 2019
- Posted
- July 3, 2019
- Terminated
- May 12, 2020
- Recall Number
- Z-1928-2019
- Quantity
- 9 units
- Firm Location
- Indianapolis, IN
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.
Distribution
US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA
Lot / Code Info
Serial Numbers - 1001 through 1037, and 502
Root Cause
Nonconforming Material/Component
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.