Health product recall

VITROS 250 and VITROS 350 Chemistry Systems (2019-04-08)

Starting date:
April 8, 2019
Posting date:
April 29, 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-69754

Last updated: 2019-04-30

Affected Products

A. VITROS 250 Chemistry System
B. VITROS 350 Chemistry System

Reason

Ortho Clinical Diagnostics determined that VITROS CK Slides do not meet the current on-analyzer stability time of < 1 week when using VITROS 250 or 350 Systems. An internal investigation has shown that quality control results drifted low (i.e., > 2 within lab Standard Deviations (SD) for VITROS Performance Verifiers) when using cartridges stored on the system for less than 7 days.
This issue is related to the humidity control of Slide Supply 2 on VITROS 250/350 Systems.
Ortho has confirmed that CK results generated using VITROS 4600, 5600, XT 7600 and 5,1 FS Systems are NOT affected by this issue.

Affected products

A. VITROS 250 Chemistry System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

680 1759

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

B. VITROS 350 Chemistry System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

680 2153

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