SteriTec Biological Indicator Test Packs Recalled for Readout Time Issues
SteriTec is recalling specific lots of Getinge Assure Accufast BI Test Packs because the readout 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. The hazard involves a performance specification issue (readout time) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity.
Plain-English summary
Steritec Products Mfc. Co., Inc. is recalling 10,170 units of Getinge Assure Accufast BI Test Packs with 5 Controls. The affected products are identified by SteriTec Product Code PL 395 and Distributor Product Code 61301606638. The specific lots involved are 121101-447 and 121101-444.
The recall was initiated because Mesa Labs, based in Bozeman, MT, informed SteriTec Products, Inc. that the readout time for the EZTest Steam and Smart-Read Biological Indicators is not in specification with the label claims. These test packs are designed for biological testing of 3 or 4 minutes or longer at 132 degrees (270) and 3 minutes at 135 pre-vacuum steam sterilizers.
The affected units were distributed worldwide, including nationwide in the US and in Argentina, Australia, Canada, the British Virgin Islands, the Czech Republic, Italy, and Turkey. Users should check their inventory for the specific lot numbers listed above and stop using the affected products.
The recalled product
- Product
- 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…
- Manufacturer
- Steritec Products Mfc. Co., Inc.
- Affected units
- 10,170
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.:121101-447 and 121101-444
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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