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Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)-… recallZ-0560-2024 · Inpeco S.A. · initiated Nov 3, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Inpeco S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.

FDA root cause category: Software Design Change

What the company is doing

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: [email protected] Phone: (+41) 91 9118 224

Recall details

Recall number
Z-0560-2024
Status
Open, Classified
Initiated by the company
Nov 3, 2023
Posted by the FDA
Dec 15, 2023
Recalling firm
Inpeco S.A.
Quantity
1 unit US: 14 units OUS
Product code
CEM
FDA submissions
K121012
Distribution
Worldwide - US Nationwide distribution in the state of MA and the countries of AUSTRIA, BELGIUM, DENMARK, ITALY, NORWAY, SPAIN.

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K121012 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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