Beckman Coulter · Model Immage 800
Plot UDR data curves Ability to utilize existing buffers and diluents for UDRs Perform single-point calibration updates Enter reagent-specific information Utilize within-lot calibration Flag antigen excess Sample load while the instrument is running delivers speed and convenience Patented dynamic blanking methodology minimizes the chances of interferences from non-specific reactions Integrated antigen excess solution eliminates the need to prepare antigen excess solution Bar-coded, liquid, ready-to-use reagents maximize efficiency Single-point calibration verification provides labor and time saving Rate Nelphelometry delivers timely, accurate analysis of specific proteins Rate Inhibition Nephelometry detects the presence and level of therapeutic drugs Rate NIPIA (Near Infrared Particle Immunoassay) increases analytical sensitivity and expands the IMMAGE systems test menu to include high-sensitivity assays Rate Inhibition NIPIA accurately detects low molecular weight therapeutic drugs
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Symptoms: Aspiration error, short sample, carryover.
Root cause: Clot/crystal obstruction.
Symptoms: Clogs, high blank, QC fail.
Root cause: Pump tube wear, air in line.
Symptoms: Incubator out of range.
Root cause: Failed heater/fan or sensor.
Symptoms: Low signal, wavelength drift.
Root cause: Lamp/LED or monochromator aging.
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Frequent R&R on high-throughput analyzers.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Xenon / LED light source | Periodic replacement | $$$ | Moderate |
| Centrifuge rotor & bearings | Major service part | $$$ | Difficult |
| Incubator heater / fan | Periodic replacement | $$ | Moderate |
| Sample aspiration probe Frequent R&R on high-throughput analyzers. | Periodic replacement | $$$ | Moderate |
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 structured starting point derived from the failure modes above. 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.
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.
IRISpec CA failures for glucose.
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.
The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
Iris International noted loose or missing analyte pads found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCITY System.
Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results.
The recall was initiated because the listed lots of Rheumatoid Factor (RF) Reagent might produce false positive results. A false positive result might lead to additional unnecessary testing.
The recall was initiated because Beckman Coulter has confirmed an Immage Systems Wash Solution Lot 71744 was manufactured by a Beckman European facility and not intended to be used in the U.S. However, this lot was inadvertently shipped to the U.S. and delivered to five customers.
Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots of IMMAGE BUF1. Some lots of BUF1 have been reported to cause high shifts in recovery of control or patient samples. Quality Control failures may result after replacing BUF1 with a different lot.
The recall was initiated because Beckman Coulter has confirmed an issue with the AutoMate Sample Processing Systems. If during the recovery from Error 81201001, a stuck sample carrier with a tube is moved backwards to the loading position, sample tube/input tray information will become mismatched for samples being loaded onto the AutoMate.
IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration.
Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).
low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.
The expiration date encoded on the IMMAFE Antideoxyribonuclease B (DNB) reagent card for lot number M106152G is incorrect and should be replaced with the one sent having a 'G' which is printed after the lot number on the reagent bar code card. Cartridge expiration dates are correct.
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