Model Number AS480 |
Device Problems
Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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As no product problem has been found, as investigation is ongoing; the malfunction could not be verified as an instrument or product specific malfunction.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.Patient id, age, gender, weight, ethnicity and race: patient information has not been provided by the user.
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Event Description
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On (b)(6) 2022, the customer from (b)(6) reported that the probe of the instrument was leaking buffer on the slides in between washes, thereby diluting the reagents on the slide.Some slides including the controls showed staining alteration.The customer can complete testing on other two autostainers.This investigation thus far has yet to identify any instrument malfunction.Once resolution has been confirmed this new information will be provided via supplemental report.The following parts were ordered: 3-way pinch valve, aspiration and dispense check valve and tube/panel mounting kit autostainer.The malfunction of these parts may lead to staining alteration, therefore the case was reported to fda.No harm or misdiagnosis was indicated.
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Manufacturer Narrative
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This malfunction may potentially impact staining performance.No erroneous staining result was reported by the customer in connection with this incident.No patient or user harm was indicated.
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Event Description
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The fse inspected the instrument and found that the 3 way pinch valve, aspiration and dispense check valve were defective.The parts were replaced while the buffer pump was replaced precautionary.All tests were performed, the instrument is within specifications and available to the user.
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Search Alerts/Recalls
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