
Biomerieux · Model Vidas
Just ‘Load and Go’ Easy access to patient files Specific management of emergency tests Workflow optimisation through bidirectional connection User-friendly graphic interface Batch or single testing - all VIDAS assays are in single-dose format Simultaneous processing of different parameters Bar-code identification of patients and reagents Data saved on CD-Rom Events recorded in real time.
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: Controls out of range, calibration fails, flagged results on one or more assays.
Root cause: Reagent pack issue, a probe / dispense fault, incubation-temperature drift, or a detector / optics fault.
Symptoms: Short aspiration, no dispense, clot / level-sense errors, carryover.
Root cause: Clogged or bent probe, a syringe / pump fault, or a level-sense fault.
Symptoms: High background / noise, poor precision, elevated blanks.
Root cause: Blocked wash-station nozzles or a wash-pump / vacuum fault.
Symptoms: Assay drift or bias, incubation-temperature alarm.
Root cause: Incubator heater or temperature-sensor fault.
Symptoms: Low signal, high CV, detector-error message.
Root cause: PMT / detector ageing or an optics 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 |
|---|---|---|---|
| Sample / reagent probe | Periodic replacement | $$ | Moderate |
| Syringe / dispense pump | Periodic replacement | $$ | Moderate |
| Wash-station nozzles / pump tubing | Frequent wear item | $ | Moderate |
| Incubator heater / temperature sensor | Major service part | $$ | Moderate |
| Detector / PMT module | Major service part | $$$ | Difficult |
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.
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.
Invalid calibrations (out of range high) while using the product.
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01).
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.
Invalid calibration with low calibrator S1 while using the product.
Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.
Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.
Product is not approved or authorized for distribution in the US.
Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL.
Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.
The product may give false positive results.
Kit may contain incorrect components
Product's decrease in sensitivity may result in false negative results
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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