Recall Z-1868-2013 ยท FRC Indicator, Biological Sterilization Process
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
| Date | Aug 1, 2013 (initiated Jun 4, 2013) |
| Status | Terminated |
| Reason | 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 | 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 BI-Support@mesalabs.com. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093794 | SMART-READ EZTEST-STEAM SCBI AND TEST PACK Sgm Biotech, Inc., May 14, 2010 |