Aug

2016

Cl II AUTOCOMP6 XPS High Speed Compounder

Company: The Metrix Company
Date of Enforcement Report 8/3/2016
Class lI:

PRODUCT

AUTOCOMP6 XPS High Speed Compounder REF 58810
Recall Number Z-2257-2016

REASON
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

RECALLING FIRM/MANUFACTURER
The Metrix Company on 6/23/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
16 devices

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

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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Cl II AUTOCOMP6 XPS High Speed Compounder

Amy Sellers

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