bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux,
FDA device recall Z-1177-2014 · posted 2014-03-12 · Terminated
Recall details
- Recalling firm
- Biomerieux Inc
- Reason for recall
- 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.
- Action taken
- The firm sent a recall notification letter to all of their consignees on 2/10/2014.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LIB
- Quantity affected
- 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.
- Date initiated
- 2014-02-10
- Date posted
- 2014-03-12
- Date terminated
- 2017-03-16
- Location
- Hazelwood, MO
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