FDA-Device2018-04-04Class II

SporAmpule Biological Indicator Catalog Number SPS5-100

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
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-1274-2018

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