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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Mesa Laboratories, Inc., Bozeman Manufacturing Facility: Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. ; Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

Agency Publication Date: August 1, 2013
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Affected Products

Product: Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

Lot No S-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No S-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15 ; Lot No S-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.

Product: Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.

Lot No SR-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21; Lot No SR-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15. Lot No SR-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 65544
Status: Resolved
Manufacturer: Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Manufactured In: United States
Units Affected: 2 products (865/25 ct boxes, 414/100 ct boxes, 307/500 ct boxes; 2447/100 count boxes)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.