FDA-Device2018-04-04Class II
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
Mesa Laboratories Bozeman Manufacturing Facility
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
28,930 units
Manufactured in
625 Zoot Way, Boseman, MT, United States
Products
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1273-2018Don't want to check this manually?
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