Mesa Laboratories Bozeman Manufacturing Facility recalls SporAmpule Biological Indicator Catalog Number SPS5-100
- Recall date
- February 12, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1274-2018
- FDA classification
- Class II
- Brand / firm
- Mesa Laboratories Bozeman Manufacturing Facility
- Sold / distributed
- United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
Why it was recalled
The concentration of bromocresol purple in the recalled lots does not conform to specification.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SporAmpule Biological Indicator Catalog Number SPS5-100
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