FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: 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.
- Recall number
- Z-1394-2009
- Recalling firm
- Roche Diagnostics Corp.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-04-01
- Posted
- 2009-05-20
- Terminated
- 2009-12-07
- Reason
- 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.
- Root cause
- 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
- 498 of all products.
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28