Z-1177-2014 Class II Terminated
FDA device recall Z-1177-2014 was initiated by Biomerieux Inc on Feb 10, 2014 and is designated Class II. 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… The recall status is terminated (terminated Mar 16, 2017). Affected quantity: 471 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 19, 2014
- Initiation Date
- Feb 10, 2014
- Termination Date
- Mar 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 471 instruments
Product Description
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
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.
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.
Code Information
Serial number range: AS 180-00001 to AS 180-00476
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1177-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026