Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Server as follows: v.8.04.02.10, catalog no. 04785568001; v.8.04.03.01, catalog no. 04785568002; and v.8.06.02, catalog no. 05109019001. 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.
This recall has been terminated (originally issued May 20, 2009).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- April 1, 2009
- Posted
- May 20, 2009
- Terminated
- December 7, 2009
- Recall Number
- Z-1394-2009
- Quantity
- 498 of all products.
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
All units.
Root Cause
Component design/selection
Action Taken
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.