FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
Recall
- Recall Number
- Z-2198-2020
- Event Number
- 85469
- Firm
- Inpeco S.A. Via San Gottardo 10 Lugano Switzerland
- FEI Number
- 3010825766
- Product Code
- CEM
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- April 7, 2020
Description
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
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.
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
US Nationwide distribution including in the states of IL, NY.
71 systems