Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1868-2013 · Posted 2013-08-01

Recalling FirmMesa Laboratories, Inc., Bozeman Manufacturing Facility
Recall StatusTerminated
Product CodeFRC
Date Initiated2013-06-04
Date Terminated2013-11-22
Product Quantity2447/100 count boxes

Reason for Recall

Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

Firm Action

Mesa Labs sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions contact Mesa Labs at [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093794SMART-READ EZTEST-STEAM SCBI AND TEST PACKSgm Biotech, Inc. · 2010-05-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑