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

Recall Z-1868-2013 — Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

U.S. FDA — Device Enforcement · United States · 2013-06-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1868-2013
Date of alert
2013-06-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Product category
device
Product type
Devices
Reported risk: Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
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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