The Recall Desk
ModerateFDA (Devices)·Z-2259-2016·Announced 2016-08-03

Metrix AUTOCOMP6 High Speed Compounder Recalled for Dispensing Accuracy Issues

The Metrix Company is recalling 323 AUTOCOMP6 High Speed Compounders because the devices cannot meet designed accuracy specifications when dispensing into bags.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

The Metrix Company is recalling 323 units of the AUTOCOMP6 High Speed Compounder. The recall was initiated after an issue was identified following a redesign of the auto compounding device. The compounders are unable to meet the designed accuracy specification when dispensing into bags.

Upon reviewing the initial design of the device, it was determined that dispensing volume validation was not properly conducted. Consequently, none of the compounders currently on the market can meet the stated specifications.

The affected products were 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. The products were also distributed internationally to Australia, Canada, the Dominican Republic, Malaysia, Turkey, and the United Kingdom. The recall covers serial numbers 1006 through 1175 and 2001 through 2163.

The recalled product

Product
AUTOCOMP6 High Speed Compounder
Manufacturer
The Metrix Company
Affected units
323

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)

  • 1006
  • 1007
  • 1008
  • 1009
  • 1010
  • 1011
  • 1012
  • 1013
  • 1014
  • 1015
  • 1016
  • 1017
  • 1018
  • 1019
  • 1020
  • 1021
  • 1022
  • 1023
  • 1024
  • 1025

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.

See all 8 products in this recall →

Same manufacturer · The Metrix Company

See all →