| Date Initiated by Firm |
November 03, 2023 |
| Date Posted |
December 15, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0560-2024 |
| Recall Event ID |
93423 |
| 510(K)Number |
K121012
|
| Product Classification |
Electrode, ion specific, potassium - Product Code CEM
|
| Product |
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.
Hardware versions: FLX-247-00
Firmware versions: COBASa_2.2.0, COBASa_2.3.0 |
| Code Information |
FlexLab UDI-DI:07640172340004
Hardware versions: FLX-247-00
Firmware versions: COBASa_2.2.0, COBASa_2.3.0
Serial Number US:
FLX.0208
Serial Numbers OUS:
Serial Number
FLX.0116
FLX.0165
FLX.0178
FLX.067
FLX.0127
FLX.0128
FLX.0150
FLX.0154
FLX.012
FLX.0121
FLX.0132
FLX.031
FLX.048
FLX.049
|
Recalling Firm/
Manufacturer |
Inpeco S.A.
Via San Gottardo 10
Lugano Switzerland
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
Software Design Change |
| Action |
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 |
| Quantity in Commerce |
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.
|
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = CEM and Original Applicant = INPECO S.P.A.
|
