FDA-Device2013-08-07Class II
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.
Steritec Products Mfc. Co., Inc.
Hazard
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Sold states
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Affected count
5000 units
Manufactured in
74 Inverness Drive East, N/A, Englewood, CO, United States
Products
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1827-2013Don't want to check this manually?
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