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Terminated

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

FDA Recall Z-1928-2019 · Posted 2019-07-03

Recall StatusTerminated
Product CodeJQP
Date Initiated2019-04-04
Date Terminated2020-05-12
Product Quantity9 units

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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