—#80699

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.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All units.

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2009-04-01
Posted by FDA: 2009-05-20
Terminated: 2009-12-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80699. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.