Metrix AUTOCOMP6 XPS High Speed Compounder Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling 16 AUTOCOMP6 XPS High Speed Compounders because they cannot meet designed accuracy specifications when dispensing into bags.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failing to meet accuracy specifications, which poses a risk of harm without reported injuries, fitting the 'High' severity criteria.
Plain-English summary
The Metrix Company is recalling 16 units of the AUTOCOMP6 XPS High Speed Compounder (REF 58810). The recall was initiated after an issue was identified following a redesign of the auto compounding device.
The device cannot meet the designed accuracy specification when dispensing into bags. A review of the initial design determined that dispensing volume validation was not properly conducted, and none of the compounders on the market can meet the stated specifications.
The affected devices were distributed to medical facilities in the United States and internationally. US distribution included facilities in Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, and Washington. International distribution included Australia, Canada, the Dominican Republic, Malaysia, Turkey, and the United Kingdom. Users should contact The Metrix Company for further instructions.
The recalled product
- Product
- AUTOCOMP6 XPS High Speed Compounder REF 58810
- Manufacturer
- The Metrix Company
- Hazard
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 000001
- 003002
- 003003
- 003004
- 003005
- 003006
- 003007
- 003008
- 003009
- 003010
- 003011
- 003012
- 003013
- 003014
- 003015
- 003016
- 003017
- 003018
- 003019
- 003020
Distribution
Part of a larger recall action
This product is one of 8 recalled by The Metrix Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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