Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Getinge Assure Accufast BI Test Pack w/ 5 Controls Recalled by Steritec Products Mfc. Co., Inc. Due to Mesa Labs, based out of Bozeman, MT, informed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Steritec Products Mfc. Co., Inc. directly.
Affected Products
Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
Quantity: 10,170 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Steritec Products Mfc. Co., Inc.
Steritec Products Mfc. Co., Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report