FDAFDA · Food and drugs·Recall number Z-2257-2016
AUTOCOMP6 XPS High Speed Compounder REF 58810
Published August 3, 2016 · Recall initiated: June 23, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Metrix Company
- Distributor
- 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
- Lot
- 000001, 003002, 003003, 003004, 003005, 003006, 003007, 003008, 003009, 003010, 003011, 003012, 003013, 003014, 003015, 003016, 003017, 003018, 003019, 003020, 003023, 003024, 003025, 003026, 003027, 003028, 003029, 003030, 003031, 003036, 003037, 003038, 003039, 003040, 003041, 003042, 003043, 003044, 003045, 003046, 003047, 003048, 003049, 003050, 003051, 003052, 003053, 003054, 003055, 003056, 003057
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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