Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2258-2016 — AUTOCOMP6 XP High Speed Compounder REF 58810

U.S. FDA — Device Enforcement · United States · 2016-06-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2258-2016
Date of alert
2016-06-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
The Metrix Company
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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