16
May
2018

FlexLab Laboratory Automation System Cl II

0

Company:Inpeco S.A.
Date of Enforcement Report 5/16/2018
Class lI:

PRODUCT

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Recall Number: Z-1798-2018

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

RECALLING FIRM/MANUFACTURER
Inpeco S.A. Lugano Switzerlandon 2/13/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
NY and IL

DISTRIBUTION
NY and IL

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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