Recall Z-0023-2013 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Biomerieux Inc
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
| Date | Oct 9, 2012 (initiated Aug 28, 2012) |
| Status | Terminated |
| Reason | The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result. |
| Root cause | Labeling design |
| Action | bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" letter dated August 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return. Contact Customer Service at 1-800-682-2666 for questions regarding this notice. |
| Quantity | 350 systems |
| Distribution | Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.