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U.S. Department of Health and Human Services

Class 3 Device Recall cobas p 501 post analytical unit

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  Class 3 Device Recall cobas p 501 post analytical unit see related information
Date Initiated by Firm April 04, 2019
Date Posted July 03, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-1927-2019
Recall Event ID 82651
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Code Information Serial Numbers - 1001 through 1044
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Customer Support Center
800-428-2336
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 4 units
Distribution US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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