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The Metrix Company recalls AUTOCOMP6 High Speed Compounder
Recalled August 3, 2016 · FDA recall Z-2259-2016 · The Metrix
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. · FDA Class II
Units
323
Sold at
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
Description
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.
Product
AUTOCOMP6 High Speed Compounder
Manufacturer(s)
The Metrix Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →