Health product recall

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

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

VITROS XT 7600 Integrated System

Lot or serial number

Software Versions 3.4 and 3.4.1.

Model or catalog number
  • 684 4461
Companies
Manufacturer
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES