FDA-Device2016-08-03Class II
AUTOCOMP6 High Speed Compounder
The Metrix Company
Hazard
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.
Sold states
Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
Affected count
323
Manufactured in
4400 Chavenelle Rd, N/A, Dubuque, IA, United States
Products
AUTOCOMP6 High Speed Compounder
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2259-2016Don't want to check this manually?
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