Mesa Smart-Read EZTEST Biological Indicator Monitor Recall for Labeling Error
Mesa Laboratories is recalling Smart-Read EZTEST Biological Indicator Monitoring Systems because the read-out time does not match label claims.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling/specification discrepancy regarding read-out time rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity.
Plain-English summary
Mesa Laboratories, Inc. is recalling the Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. This product is intended for use in determining the efficacy of steam sterilization processes. The recall involves 2447/100 count boxes of the self-contained steam biological indicator.
The recall was initiated because Mesa recently determined that the read-out time is not in specification with the label claims. This discrepancy affects the accuracy of the product's performance relative to its stated specifications.
The affected products were distributed worldwide, including the United States and numerous international markets. Specific lots involved in the recall are SR-444, SR-445, and SR-447, with manufacture dates ranging from January 2013 to March 2013. Users should check their inventory for these specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Mesa Laboratories, Inc., Bozeman Manufacturing Facility under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Mesa Laboratories, Inc., Bozeman Manufacturing Facility
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