VITROS XT 7600 Integrated System (2019-03-20)

Starting date:

March 20, 2019

Posting date:

April 5, 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-69500

Last updated: 2019-04-05

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  Reason
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  Affected products

Affected Products

VITROS XT 7600 Integrated System

Reason

Due to an undetected mechanical interference, a MicroSlide may not be properly positioned into the Tip Locator. If this occurs, the sample may not be properly dispensed on the slide. Ortho Clinical Diagnostics identified during internal testing that the threshold used in locating the dispense blade position in the Tip Locator is incorrect. If an undetected MicroSlide position error occurs, a condition code is inadvertently not reported by system and the potentially erroneous test result is generated. VITROS XT MicroSlides, MicroWell and MicroTip assays are NOT affected.

Affected products