FDA recall Z-1273-2018

Mesa Laboratories Bozeman Manufacturing Facility · Class II · device

Product

ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471

Reason for recall

The concentration of bromocresol purple in the recalled lots does not conform to specification.

Distribution

United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan

Key facts

Status
Terminated
Initiation date
2018-02-12
Report date
2018-04-04
Termination date
2018-07-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boseman, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1273-2018