SteriTec Recalls Smart-Read Biological Indicators Due to Readout Time Issues
SteriTec is recalling Smart-Read Biological Indicators because the readout time does not match label claims. The recall affects 5,000 units distributed worldwide.
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. The hazard involves a specification mismatch (readout time) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity involving labeling or performance discrepancies without reported harm.
Plain-English summary
SteriTec Products Mfc. Co., Inc. is recalling 5,000 units of the Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack. The recall was initiated after Mesa Labs informed SteriTec that the readout time for the biological indicators is not in specification with the label claims.
The affected product is identified by Biological Indicator Lot No. 130301. The product is designed for biological testing of re-vacuum steam sterilizers. Distribution was worldwide, including the United States (nationwide), Argentina, Australia, Canada, the British Virgin Islands, the Czech Republic, Italy, and Turkey.
Users of these biological indicators should stop using the affected lot and contact the manufacturer or distributor for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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…
- Manufacturer
- Steritec Products Mfc. Co., Inc.
- Affected units
- 5,000
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)
- Affected Biological Indicator Lot No.:130301
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Steritec Products Mfc. Co., Inc. 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 8 products in this recall →Related recalls
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