Boseman, MT, United States
Mesa Laboratories Bozeman Manufacturing Facility recalls
1 recall recorded since 2018, most recently on 12 February 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 February 2018
- Terminated
- 3 July 2018
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1274-2018, Z-1273-2018
- SporAmpule Biological Indicator Catalog Number SPS5-100
- ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.