BioMerieux PREVI Isola System Recalled for Potential False Negative Results
BioMerieux is recalling 471 PREVI Isola Systems because they may fail to dispense urine samples, potentially leading to false negative growth 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 involves a diagnostic medical device that may produce false negative results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
BioMerieux Inc is recalling 471 units of the PREVI Isola System, a general-purpose microbiology diagnostic medical device. The recall covers instruments with serial numbers ranging from AS 180-00001 to AS 180-00476.
The firm determined that the product may fail to dispense the sample to the agar plate when used with urine specimens. This malfunction could result in a "false" negative growth result, meaning the device might indicate no bacterial growth when bacteria are actually present.
The affected devices were distributed to laboratories and facilities in Alaska, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, and Wisconsin. Users should contact BioMerieux for instructions on how to return or replace the affected instruments.
The recalled product
- Product
- bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
- Manufacturer
- Biomerieux Inc
- Affected units
- 471
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 number range: AS 180-00001 to AS 180-00476
Distribution
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