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U.S. Department of Health and Human Services

Class 2 Device Recall Roche cobas 6000 analyzer (cobas c 501 and cobas e 601)

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  Class 2 Device Recall Roche cobas 6000 analyzer (cobas c 501 and cobas e 601) see related information
Date Initiated by Firm April 01, 2009
Date Posted May 20, 2009
Recall Status1 Terminated 3 on December 07, 2009
Recall Number Z-1393-2009
Recall Event ID 51561
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Standard as follows: v.8.04.02.10, catalog no. 04785550001; v.8.04.03, catalog no. 04785550002; and v.8.06.02, catalog no. 05108993001.

The device is used to interface hospital LIS systems with Roche c 6000 analyzers and allows order and result communication to occur between the two systems.
Code Information All units.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 Some data alarm flags do not transfer from the analyzer to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware.
FDA Determined
Cause 2		 Component design/selection
Action Consignees were notified by "Urgent Medical Device Correction" letter dated April 1, 2009 and instructed to add error codes to the Instrument Manager driver and to contact the manufacturer of their LIS for instructions on adding data alarm codes to the LIS. Consignees were also instructed to complete the attached fax form after adding the error codes to their system and fax to 1-888-345-4690. Contact Roche Diagnostics Technical Support at 1-800-428-2336 for questions about information contained in the notification letter.
Quantity in Commerce 498 of all products
Distribution Nationwide Distribution.
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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