Recalls / —
—#125497
Product
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
- FDA product code
- LIB — Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- Serial number range: AS 180-00001 to AS 180-00476
Why it was recalled
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 (FDA determination)
Software design
Action the firm took
The firm sent a recall notification letter to all of their consignees on 2/10/2014.
Recalling firm
- Firm
- Biomerieux Inc
- Address
- 595 Anglum Rd, Hazelwood, Missouri 63042-2320
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2014-02-10
- Posted by FDA
- 2014-03-12
- Terminated
- 2017-03-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #125497. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.