cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is
FDA device recall Z-1612-2018 · posted 2018-05-03 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corporation
- Reason for recall
- The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
- Action taken
- ROCHE sent an Urgent Medical Device Correction Letter dated February 22, 2018, via UPS to affected customers. Customers were instructed to complete the following: " 1) Use the Return to Setup and Exit buttons to ensure execution of scheduled AutoQC measurements as described in this Urgent Medical Device Correction (UMDC); 2) Check to see if the next scheduled AutoQC measurement is performed to ensure the AutoQC scheduler is working as expected; 3) If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site; 4) Complete the attached fax form (TP-00146) and fax it to 1-844-491-7776 or scan and email to roche7570@stericycle.com; 5) File this UMDC for future reference. Customers with questions should contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 1026 total products
- Distribution
- USA ( nationwide)
- Date initiated
- 2018-02-22
- Date posted
- 2018-05-03
- Date terminated
- 2019-11-15
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE DIAGNOSTICS OMNI S ANALYZER (K032311) | Roche Diagnostics Corp. | 2003-10-17 |