VITROS XT 7600 Integrated System (2019-03-10)

Starting date:

March 10, 2019

Posting date:

March 22, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69394

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  Reason
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  Affected products

Affected Products

VITROS XT 7600 Integrated System

Reason

Ortho Clinical Diagnostics identified this issue during internal testing. When the unreported sample dispense error occurs, either a smaller volume of sample or no sample is dispensed on a slide, and the associated condition code is not reported to the operator via the Status console or Condition Review screen. Samples with increased viscosity are more susceptible to these sample dispense errors.

If an unreported sample dispense error occurs, the expected condition code (TE6-47E or TE6-47J) is not reported, and the test result for the sample is not suppressed. Other algorithms that are designed to detect conditions involving smaller than expected volumes due to bubbles, clots or pressure leaks are functioning as expected.

Affected products