Events

Recall of Device Recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inpeco S.A..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79645
  • Event Risk Class
    Class 2
  • Event Number
    Z-1798-2018
  • Event Initiated Date
    2018-02-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162888
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Module may freeze without generating user warning. there is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
  • Action
    On 2/13/18, distributors were notified by emailed Technical Service Bulletin. The recalling firm also released a Customer Letter to be forwarded to final customers (labs) by distributors. The Customer Letter advised users of the issue and informed that the recalling firm would be visiting sites to upgrade the firmware to resolve the issue. All impacted customers were instructed to complete and return the Receipt Confirmation within 7 days. Contact provided: Giorgia Amabile - Quality Assurance & Regulatory Affairs Manager, giorgia.amabile@inpeco.com, (+41) 91 9118 258.

Device

Device Recall FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2)
  • Model / Serial
    Serial Numbers:  Accelerator a3600 -  ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214  FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181  Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095  Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributors in 2 states: NY and IL.
  • Product Description
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
  • Manufacturer
    Inpeco S.A.

Manufacturer

Inpeco S.A.
  • Manufacturer Address
    Inpeco S.A., Via San Gottardo 10, Lugano Switzerland
  • Manufacturer Parent Company (2017)
    Inpeco Group Sa
  • Source
    USFDA