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U.S. Department of Health and Human Services

Class 2 Device Recall Cobas c8000 Modular Analyzer Series Cobasc502

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 Class 2 Recall
Cobas c8000 Modular Analyzer Series Cobasc502
see related information
Date Posted April 10, 2014
Recall Status1 Open
Recall Number Z-1449-2014
Recall Event ID 67762
Premarket Notification
510(K) Number
K100853 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
Code Information not applicable
Recalling Firm/
Manufacturer
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis, Indiana 46256-1025
For Additional Information Contact Todd Siesky
317-521-4696
Manufacturer Reason
for Recall
The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures
FDA Determined
Cause 2
PRODUCTION CONTROLS: Software Manufacturing/Software Deployment
Action March 17, 2014 all consignees will be notified by Urgent Medical Device Correction sent via UPS Ground (receipt required). The notice identified the issue, root cause, affected assays with clinical significance. Consignees were instructed to follow the steps listed in the Urgent Medical Device Correction to correctly activate the ICVC and verify the correction. If your system is not connected to the Internet through the cobas link, and you do not have the option to run the affected reagents on an alternate system (i.e., cobas c 311 or cobas c 501 analyzer), please contact the Roche Support Network Customer Support Center at 1-800-428-2336 to have an update scheduled via a Roche Field Representative. If your system is connected to the Internet through the cobas link, follow the steps below: " Remove all reagent cobas c packs on board your cobas c 502 module for the assays listed on pages 1-2. " Dispose of these reagent cobas c packs according to your local waste management ordinances. " Load new cobas c packs for the affected assays, and visually verify the ICVC is performed. " Complete the attached fax form (5326-00-0314) and fax it to 1-888-276-6166. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " File this Urgent Medical Device Correction (UMDC) for future reference.
Quantity in Commerce 76 units
Distribution USA Nationwide Distribution including San Juan PR
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ROCHE DIAGNOSTICS CORP.
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