BioMérieux PREVI Isola System Recall for False Negative Results
BioMérieux is recalling PREVI Isola Systems because they may fail to dispense specimens, leading to false negative microbiological test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (false negative results in microbiological testing) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
BioMérieux, Inc. is recalling 350 units of the PREVI Isola System, catalog numbers 29500 and 29500R. These devices are intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
The recall is being issued because the instrument may not dispense the specimen onto the pre-poured media, which can result in a false negative test result. The affected units have serial numbers ranging from AS180-00001 to AS180-00376.
The products were distributed nationwide in the United States, 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, as well as in Canada. Users should contact BioMérieux for instructions on how to return or replace the affected devices.
The recalled product
- 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.
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 350
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers AS180-00001 to AS180-00376.
Distribution
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