Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
bioMerieux PREVI Isola System (General purpose Recalled by Biomerieux Inc Due to The firm has determined the product may fail...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomerieux Inc directly.
Affected Products
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Quantity: 471 instruments
Why Was This 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.
Where Was This Sold?
This product was distributed to 25 states: AK, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MO, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WI, DC
About Biomerieux Inc
Biomerieux Inc has 368 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report