Z-2198-2020Class II

FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple...

Name: Z-2198-2020 FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple...
Creator: Inpeco S.A.
Published: 2020-04-07
License: https://open.fda.gov/license/

Inpeco S.p.A. / initiated 2020-04-07 / Open, Classified / root cause: software

FDA source

Inpeco S.A. began a recall of FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation on 2020-04-07. FDA classified it as Class II and gives the reason as "Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the...". 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-2198-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-04-07
Posted: 2020-06-01
Recalling firm: Inpeco S.p.A.
Product: FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
Root cause tag: software
FDA root cause: Software design
Action: Urgent: Medical Device Correction dated 03/30/2020 were sent to customers. The impacted modules are the Aliquoter Modules (Inpeco Part Number FLX-212) with a firmware version prior to the following: AQMb_3-3-0.H86; AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86; xAQMb_1-1-0.elf; Action to be taken by the user To avoid the risk of contamination take the following precaution: 1) Discard the Primary Tube flagged with Clot Detection error or manage it according to your laboratory guidelines considering that it may be diluted. 2) Call Service Assistant in case the frequency of the Clot Detection Error increases (more than 5 consecutive Clot Detection Errors). Your service provider will contact you to schedule the firmware upgrade. Until the service visit please maintain awareness on this notice. Please complete and return the "Customer Letter Receipt Confirmation and Implementation CHeck form" attached to this letter with 15 days directly at the email address specified in the email communication. Contact reference person: FOr any clarificatino you may need, do not hesitate to ocntact: Eva Balzarotti - REgulatory Affairs Manager E-mail: [email protected] Phone: (+41) 91 9118 224
Quantity in commerce: 71 systems
Distribution: US Nationwide distribution including in the states of IL, NY.
Product codes and lots: Serial Numbers: FLX.008 FLX.0105 FLX.0106 FLX.0107 FLX.0113 FLX.0114 FLX.0115 FLX.0116 FLX.0118 FLX.0119 FLX.012 FLX.0121 FLX.0124 FLX.0125 FLX.0126 FLX.0127 FLX.0128 FLX.0129 FLX.0131 FLX.0135 FLX.0136 FLX.0138 FLX.014 FLX.0140 FLX.0141 FLX.0143 FLX.015 FLX.0152 FLX.0155 FLX.0158 FLX.0161 FLX.0164 FLX.017 FLX.018 FLX.0196 FLX.020 FLX.021 FLX.022 FLX.023 FLX.027 FLX.029 FLX.030 FLX.031 FLX.032 FLX.033 FLX.037 FLX.038 FLX.039 FLX.043 FLX.044 FLX.046 FLX.047 FLX.050 FLX.051 FLX.052 FLX.056 FLX.060 FLX.064 FLX.071 FLX.072 FLX.074 FLX.075 FLX.076 FLX.077 FLX.080 FLX.082 FLX.083 FLX.093 FLX.101 FLX.102 TSH.003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2198-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2198-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-10	2020-06-01
Z-2199-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-10	2020-06-01
Z-2200-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-10	2020-06-01

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)