
Biomerieux · Model Previ Color Gram
Standardized result that is not user-dependent Finished product ready to read in as little as 5 minutes Assurance of quality – no worry of cross contamination Minimal hands-on time and clean up Reduces reagent use and waste Touchscreen interface for easy-handling of the system Level monitoring for waste and reagents to avoid spillover and staining issues Automated cleaning to help lessen troubleshooting issues Program memory to customize protocols based on samples Full traceability of reagents, users, maintenance, and slides Quick to load, push button carousel.
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Symptoms: Stations not filling or draining, retort not filling (processor), transport arm mis-places baskets, error alarm halts the run.
Root cause: Worn pump / valve, a blocked line, a level-sensor fault, or a transport-drive / gripper fault.
Symptoms: Pressure / vacuum not achieved, poor infiltration, seal alarm.
Root cause: Worn retort door seal, a vacuum / pressure-pump fault, or a valve.
Symptoms: Slides over- / under-stained, uneven, station-time drift.
Root cause: Exhausted reagents, wrong programme, incorrect agitation, or a timing / arm fault.
Symptoms: Paraffin not molten or too hot, oven not at temperature, bath alarm.
Root cause: Heater or temperature-sensor fault.
Symptoms: Reagent fumes in the room, filter-change overdue.
Root cause: Saturated carbon filter or a fan fault.
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Reagent / paraffin pump & valves | Periodic replacement | $$$ | Difficult |
| Retort / reagent-vessel seals | Periodic replacement | $$ | Fairly easy |
| Transport-arm drive / gripper (stainer) | Periodic replacement | $$$ | Difficult |
| Bath / oven heater & temperature sensor | Major service part | $$ | Moderate |
| Activated-carbon fume filter | Frequent wear item | $ | Easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
Extracted directly from this unit's own service manual.
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola instrument.
A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).
False susceptible results
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Potential performance issue on strain categorization.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
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.
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.
AMENDED REASON FOR RECALL: The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.
Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
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