Recalls / —
—#176020
Product
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
- FDA product code
- JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K162606
- Affected lot / code info
- Lot Numbers: 18636170 18665170 18667170 18668170 18215274 18245274 18250274 18251274 18252274 18253274 18265274 18271274 19209274
Why it was recalled
AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results
Root cause (FDA determination)
Process change control
Action the firm took
Roche Diagnostics issued Urgent Medical Notification letter to Distributor (TP-00744) and end users( TP-00741) on 8/13/19. Letter identifies problem, health risk and Actions required per the UMDC: " Check to see if you have any of the affected lot number(s) of AssayTips/AssayCup Trays on your cobas e 801 module or in your laboratory stock. (See pictures for lot number locations on packaging.). " Stop using the affected lot number(s) of AssayTips/AssayCup Trays immediately. " Discard the affected lot number(s) of AssayTips/AssayCup Trays according to your local waste management guidelines. To receive replacement product, fill out the attached fax form and fax or email it according to the instructions on the form. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions
Recalling firm
- Firm
- Roche Diagnostics Operations, Inc.
- Address
- 9115 Hague Rd, Indianapolis, Indiana 46256-1025
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-08-13
- Terminated
- 2022-06-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #176020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.