VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Official notice from a government agency or its published feed.
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Worldwide - US Nationwide distribution.
Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Worldwide - US Nationwide distribution.
Hazard: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the…
View the FDA enforcement report ↗ ← All reports