PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation
FDA device recall Z-0023-2013 · posted 2012-10-09 · Terminated
Recall details
- Recalling firm
- Biomerieux Inc
- Reason for recall
- The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LXG
- Quantity affected
- 350 systems
- Distribution
- 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.
- Date initiated
- 2012-08-28
- Date posted
- 2012-10-09
- Date terminated
- 2014-09-04
- Location
- Hazelwood, MO
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