Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager
FDA device recall Z-1394-2009 · posted 2009-05-20 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 498 of all products.
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-04-01
- Date posted
- 2009-05-20
- Date terminated
- 2009-12-07
- Location
- Indianapolis, IN
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