Mesa Laboratories Recalls ProSpore Biological Indicators Due to Concentration Defect
Mesa Laboratories is recalling specific lots of ProSpore Biological Indicators because the concentration of bromocresol purple does not conform to specification.
What this means for you
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, but the source text describes a specification non-conformance without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Mesa Laboratories Bozeman Manufacturing Facility is recalling 28,930 units of ProSpore Biological Indicators. The affected part numbers are PS-6-50, PS-5-50, PS-4-10, PS-4-50, and 3471. The specific lots involved are PS-673, PS-674, and PS-675.
The recall was initiated because the concentration of bromocresol purple in these lots does not conform to the required specification. This is a Class II recall, indicating a situation that could temporarily cause or contribute to reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected products were distributed in the United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, and Jordan. Users should stop using the affected lots and contact Mesa Laboratories for further instructions.
The recalled product
- Product
- ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
- Manufacturer
- Mesa Laboratories Bozeman Manufacturing Facility
- Hazard
- Affected units
- 28,930
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 (3)
- Lots: PS-673
- PS-674
- PS-675
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Mesa Laboratories 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.
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