Z-2003-2020Class II

Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 -

Name: Z-2003-2020 Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 -
Creator: Inpeco S.A.
Published: 2020-04-07
License: https://open.fda.gov/license/

Inpeco S.p.A. / initiated 2020-04-07 / Terminated / root cause: software

FDA source

Inpeco S.A. began a recall of Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a... on 2020-04-07. FDA classified it as Class II and gives the reason as "When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples". 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-2003-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-07
Posted: 2020-05-14
Terminated: 2022-07-28
Recalling firm: Inpeco S.p.A.
Product: Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) 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 systems consolidate multiple Analytical instruments into a unified workstation.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
Root cause tag: software
FDA root cause: Software design
Action: On April 7, 2020, the firm sent an Urgent Medical Device Correction letter to all impacted customers and instructed them to return the Customer Letter Receipt Confirmation and Implementation Check form within 15 days. The customers were asked to confirm that they had read, understood, and applied all the applicable recommended actions. The impacted Customers were told that they would be contacted by their service representative to schedule the system update.
Quantity in commerce: 82
Distribution: Worldwide distribution - US Nationwide including in the states of Texas, West Virginia, South Carolina, Delaware, Louisiana, Illinois, Georgia, Florida, New York, Virginia, Arkansas, Wisconsin, California, Minnesota, Missouri, North Carolina, Utah, Michigan, Ohio, Alabama, Oklahoma, Tennessee, Kansas, Hawaii, Arizona, Washington
Product codes and lots: Serial Numbers: AML.001, FLX.0104, FLX.0105, FLX.0106, FLX.0107, FLX.0108, FLX.0112, FLX.0114, FLX.0115, FLX.0116, FLX.0118, FLX.0119, FLX.0120, FLX.0124, FLX.0125, FLX.0126, FLX.0131, FLX.0133, FLX.0134, FLX.0135, FLX.0136, FLX.0140, FLX.0141, FLX.0142, FLX.0143, FLX.015, FLX.0152, FLX.0155, FLX.0158, FLX.0161, FLX.0163, FLX.0164, FLX.017, FLX.0175, FLX.0178, FLX.018, FLX.0184, FLX.0189, FLX.019, FLX.0196, FLX.020, FLX.021, FLX.023, FLX.026, FLX.027, FLX.030, FLX.032, FLX.033, FLX.038, FLX.040, FLX.044, FLX.045, FLX.047, FLX.051, FLX.052, FLX.053, FLX.054, FLX.055, FLX.058, FLX.059, FLX.063, FLX.064, FLX.065, FLX.066, FLX.067, FLX.068, FLX.071, FLX.072, FLX.074, FLX.075, FLX.076, FLX.077, FLX.079, FLX.080, FLX.081, FLX.091, FLX.092, FLX.095, FLX.099, FLX.101, FLX.102, FLX.103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2003-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2003-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-2004-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14

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)