Recall Z-1948-2013— Ortho-Clinical Diagnostics

Name: FDA recall Z-1948-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-06

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-06-06, terminated 2018-05-17. It names 3 FDA 510(k) clearances: K081543, K063144, K031924. Product: Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.. Reason: Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2013-06-06
Terminated: 2018-05-17
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

3 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.

Reason for recall

Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.

Data sourced from openFDA. This site is unofficial and independent of the FDA.