Z-0560-2024Class II

Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system...

Name: Z-0560-2024 Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system...
Creator: Inpeco S.A.
Published: 2023-11-03
License: https://open.fda.gov/license/

Inpeco S.p.A. / initiated 2023-11-03 / Open, Classified / root cause: software

FDA source

Inpeco S.A. began a recall of Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and... on 2023-11-03. FDA classified it as Class II and gives the reason as "Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0560-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-03
Posted: 2023-12-15
Recalling firm: Inpeco S.p.A.
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
Product code: CEM Electrode, Ion Specific, Potassium
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.
Root cause tag: software
FDA root cause: 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: [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0560-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0560-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-15

Product code CEM

K121012Class IIFlexlab 3.6, Accelerator A3600Inpeco S.P.A. / cleared 2012-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)