Z-1868-2013Class II

Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy...

Name: Z-1868-2013 Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy...
Creator: Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Published: 2013-06-04
License: https://open.fda.gov/license/

Mesa Laboratories Inc / initiated 2013-06-04 / Terminated / root cause: manufacturing process

FDA source

Mesa Laboratories, Inc., Bozeman Manufacturing Facility began a recall of Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes on 2013-06-04. FDA classified it as Class II and gives the reason as "Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1868-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-04
Posted: 2013-08-01
Terminated: 2013-11-22
Recalling firm: Mesa Laboratories Inc
Product: Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Mesa Labs sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions contact Mesa Labs at [email protected].
Quantity in commerce: 2447/100 count boxes
Distribution: Worldwide Distribution: US (nationwide) and countries of: Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Egypt, Greece, India,Israel, Japan, Jordan, Malaysia, Mexico, Milanese, Netherlands, Peru, Portugal, Pozan, Romania, Spain, Sweden, Taiwan, Thailand, United Kingdom, and Uruguay.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1868-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1867-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01
Z-1868-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01

Product code FRC

K093794Class IISmart-Read Eztest-Steam Scbi and Test PackSgm Biotech, Inc. / cleared 2010-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)