# FDA recall Z-1273-2018

> **Mesa Laboratories Bozeman Manufacturing Facility** · Class II · device recall initiated 2018-02-12.

## 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

- **Recall number:** Z-1273-2018
- **Recalling firm:** Mesa Laboratories Bozeman Manufacturing Facility
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1273-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1273-2018. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
