Z-2973-2020Class II

FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to...

Name: Z-2973-2020 FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to...
Creator: Inpeco S.A.
Published: 2020-08-07
License: https://open.fda.gov/license/

Inpeco S.p.A. / initiated 2020-08-07 / Terminated / root cause: software

FDA source

Inpeco S.A. began a recall of FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory... on 2020-08-07. FDA classified it as Class II and gives the reason as "Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2973-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-07
Posted: 2020-09-16
Terminated: 2021-12-02
Recalling firm: Inpeco S.p.A.
Product: FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Root cause tag: software
FDA root cause: Software design
Action: Inpeco issued Customer Letter dated August 7, 2020 forwarded to the customers either by Inpeco (for the laboratories where Inpeco is directly the distributor) or by the Inpeco distributors. Letter states reason for recall, health risk and action to take: customers impacted by the Field Action have to complete and return the Recall Letter Receipt Confirmation and Implementation Check form attached to the Customer letter within 15 days to Inpeco or the distributor. The customers impacted by the issue will be contacted by Inpeco or the distributors to arrange a visit to upgrade the impacted modules firmware. Contact reference person: Eva Balzarotti - Regulatory Affairs Manager. E-mail: [email protected] Phone: (+41) 919118 224
Quantity in commerce: 2 US and 6 OUS
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS. NORWAY SAUDI ARABIA SOUTH KOREA SWEDEN UNITED ARAB EMIRATES
Product codes and lots: Serial Numbers: US: FLX.0133 FLX.0181 OUS: FLX.0048 FLX.0049 FLX.0121 FLX.0155 FLX.0160 FLX.0200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2973-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2973-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-16
Z-2974-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-16
Z-2975-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-16

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)