Recalls / —
—#112305
Product
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
- FDA product code
- LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Serial numbers AS180-00001 to AS180-00376.
Why it was recalled
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
Root cause (FDA determination)
Labeling design
Action the firm took
bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" letter dated August 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return. Contact Customer Service at 1-800-682-2666 for questions regarding this notice.
Recalling firm
- Firm
- Biomerieux Inc
- Address
- 595 Anglum Rd, Hazelwood, Missouri 63042-2320
Distribution
- Distribution pattern
- Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.
Timeline
- Recall initiated
- 2012-08-28
- Posted by FDA
- 2012-10-09
- Terminated
- 2014-09-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #112305. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.