Recall Z-1177-2014 ยท LIB Device, General Purpose, Microbiology, Diagnostic
Biomerieux Inc
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
| Date | Mar 12, 2014 (initiated Feb 10, 2014) |
| Status | Terminated |
| Reason | The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result. |
| Root cause | Software design |
| Action | The firm sent a recall notification letter to all of their consignees on 2/10/2014. |
| Quantity | 471 instruments |
| Distribution | Distribution was made to AK, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.