FDA-Device2018-04-04Class II
SporAmpule Biological Indicator Catalog Number SPS5-100
Hazard
The concentration of bromocresol purple in the recalled lots does not conform to specification.
Sold states
United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
Affected count
40,000 units
Manufactured in
625 Zoot Way, Boseman, MT, United States
Products
SporAmpule Biological Indicator Catalog Number SPS5-100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1274-2018Don't want to check this manually?
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