Recall Z-1177-2014
Biomerieux Inc · initiated February 10, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Codes / lots: Serial number range: AS 180-00001 to AS 180-00476
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.
FDA-determined cause: Software design
Action taken
The firm sent a recall notification letter to all of their consignees on 2/10/2014.
Details
- Recall number
- Z-1177-2014
- Initiated
- February 10, 2014
- Posted by FDA
- March 12, 2014
- Terminated
- March 16, 2017
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- 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.
- Recalling firm
- Biomerieux Inc, Hazelwood, MO