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Vitros 5600 Integrated Systems (2014-09-30)

Starting date:
September 30, 2014
Posting date:
October 9, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41709

Recalled Products

A) Vitros 5600 Integrated System (Device Licence #78571)
B) Vitros 5600 Integrated System (Device Licence #80701)

Reason

Ortho Clinical Diagnostics (OCD) has identified an anomaly with Vitros system software version 3.1. Internal testing confirmed that when using calibrator barcode labels supplied with Vitros chemistry products calibrator kit 2, calibration may not occur under specific circumstances. Consignees are being advised not to use the calibrator barcode labels for Vitros calibrator kit 2 until this anomaly is resolved in a future version of software.

Affected products

A) Vitros 5600 Integrated System (Device Licence #78571)

Lot or serial number

56000576

Model or catalog number

680 2413

Companies
Manufacturer
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES

B) Vitros 5600 Integrated System (Device Licence #80701)

Lot or serial number

56000576

Model or catalog number

680 2413

Companies
Manufacturer
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES