Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to au
FDA device recall Z-0560-2024 · posted 2023-12-15 · Open, Classified
Recall details
- Recalling firm
- Inpeco S.A.
- Reason for recall
- Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
- Action taken
- Inpeco issued Urgent Medical Device Correction Letter (Recall-identifier: 3010825766 11/06/23 002 C) via email on 11/3/23. Letter states reason for recall, health risk and action to take: Please apply the following instructions to detect the sample tubes potentially impacted by the issue (Step 1) and to manage them according to the specific occurred scenario (Step 2). If Step 1 leads to determine that the issue has not occurred, Step 2 is not to be performed. Note: The test orders status displayed on the IUI is not overwritten neither changed in any way due to the issue: it would be possible to monitor the turn-around time of sample tubes processed by the CO8 IM in order to identify any overdue sample tube with tests still to be executed. Contact your local technical support provider if you need assistance in implementing these actions. Your service provider will contact you to schedule the firmware upgrade. Until the service visit please maintain awareness on this notice and apply the actions recommended above. Transmission of this Recall Letter: Please transfer this notice to whom it might concern. Please complete and return the Customer Letter Receipt Confirmation and Implementation Check form attached to this letter within 30 days directly to the email address specified in the email communication. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-mail: regulatory.affairs@inpeco.com Phone: (+41) 91 9118 224
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- CEM
- Quantity affected
- 1 unit US: 14 units OUS
- Distribution
- Worldwide - US Nationwide distribution in the state of MA and the countries of AUSTRIA, BELGIUM, DENMARK, ITALY, NORWAY, SPAIN.
- Date initiated
- 2023-11-03
- Date posted
- 2023-12-15
- Location
- Lugano, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXLAB 3.6, ACCELERATOR A3600 (K121012) | Inpeco S.P.A. | 2012-08-31 |