Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - e 602 Roche / Hitachi MODULAR
FDA device recall Z-0378-2018 · posted 2018-01-16 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corporation
- Reason for recall
- Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
- Action taken
- Roche sent an Urgent Medical Device Correction (UMDC) sent via UPS Ground (receipt required) dated July 6, 2017, and an amended UMDC on August 31 ,2017. All consignees will be notified by Urgent Medical Device Correction sent via UPS Ground (receipt required). Customers/consignees were instructed the following: If the Tip/Cup pick up error alarm is issued then followed by the Abnormal L2-line Movement alarm on your MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer, after which the system goes into Sampling Stop, follow the steps in this UMDC and the appropriate How to Identify Potentially Mismatched Sample Results within the enclosed document. For further questions, please call (317) 521-4343.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 2517
- Distribution
- USA (nationwide) Distribution
- Date initiated
- 2017-06-29
- Date posted
- 2018-01-16
- Date terminated
- 2020-01-24
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS 8000 MODULAR SERIES ANALYZER (K100853) | Roche Diagnostics Corp. | 2010-09-09 |
| COBAS 6000 SERIES SYSTEM (K060373) | Roche Diagnostics | 2006-03-13 |
| BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER (K953239) | Boehringer Mannheim Corp. | 1995-09-25 |